# agentsite-static-version=461e409c-1ad8-41a8-b485-d7cbcfc6a916
# extedo.com

> AI-optimized mirror of extedo.com containing 247 pages totalling 62,764 words of clean markdown content, structured data, and semantic HTML. Original source: https://extedo.com. Last updated: 2026-09-24T16:32:25.001Z.

Each page is available as HTML (with JSON-LD structured data) and Markdown (text-only, ideal for LLMs and RAG).

## Homepage

- [site-root.html](/content/site-root.html): EXTEDO RIM Solutions - Software and expertise to efficiently manage your regulated documents, data, and processes within the life science industry.
 (545 words)

## Articles & Blog Posts

- [Optimize Submission Document Creation and Maintenance with EXTEDOpulse](/content/events-portal/optimize-submission-document-creation-and-maintenance-with-extedopulse.html): Webinar: Optimize Submission Document Creation and Maintenance with EXTEDOpulse (38 words)
- [resources/index.html](/content/resources/index.html): EXTEDO resources for pharma and life sciences compliance. (428 words)
- [eRA 2025](/content/events-portal/event-era-2025/index.html):  eRA 2025: Comply, Harmonize, Innovate - Concepts and Solutions to Manage Digital Transformation  in Life Sciences (7 words)
- [Webinar: ePI Masterclass - Part II: The Key Stakeholders in the ePI Space](/content/events/webinar-epi-masterclass-part-ii-the-key-stakeholders-in-the-epi-space.html): Webinar: ePI Masterclass - Part II: The Key Stakeholders in the ePI Space (568 words)
- [services/installation-and-validation-services/index.html](/content/services/installation-and-validation-services/index.html): EXTEDO provides a broad range of Computer System Validation (CSV) services to support client systems. (351 words)
- [EXTEDO Announces New Regional Partnership with Egypt for Information Dissemination | EXTEDO](/content/blog/extedo-announces-new-regional-partnership-with-egypt-for-information-dissemination.html): EXTEDO Announces New Regional Partnership with Egypt for Information Dissemination (426 words)
- [EXTEDO Expands its Global Reach in Pakistan | EXTEDO](/content/blog/extedo-expands-its-global-reach-in-pakistan/index.html): EXTEDO Expands its Global Reach in Pakistan (496 words)
- [support/customer-portal-infopage/webinar-global-implementation-of-ectd-epi-and-idmp-insights-strategies-live-demo.html](/content/support/customer-portal-infopage/webinar-global-implementation-of-ectd-epi-and-idmp-insights-strategies-live-demo.html): Webinar: Global Implementation of eCTD, ePI, and IDMP: Insights, Strategies & Live Demo (259 words)
- [support/customer-portal-infopage/webinar-structured-content-managed-data-ai-how-to-build-new-ways-for-regulated-information.html](/content/support/customer-portal-infopage/webinar-structured-content-managed-data-ai-how-to-build-new-ways-for-regulated-information.html): Webinar: Structured Content, Managed Data, & AI - How to Build New Ways for Regulated Information (197 words)
- [Choosing an ISO/IEC 27001 certified service provider: Advantages for companies and organizations | EXTEDO](/content/blog/choosing-an-iso-iec-27001-certified-service-provider-advantages-and-benefits.html): EXTEDO's Information security management system is ISO/IEC 27001 certified! But what does that mean, and how do customers benefit from this? (547 words)
- [European Medicines Agency (EMA): Quarterly System Demos 2026 | EXTEDO](/content/blog/european-medicines-agency-ema_quarterly-system-demos.html): Stay updated with EMA's 2026 Quarterly System Demos dates for essential eCTD and IDMP insights.  (267 words)
- [The EMA prepares itself for Brexit | EXTEDO](/content/blog/the-ema-prepares-itself-for-brexit/index.html): The European Medicines Agency (EMA) recently released a business continuity plan dealing with the potential implications of Brexit. (596 words)
- [Upcoming Changes in eCTD EU Module 1 Specification | EXTEDO](/content/blog/upcoming-changes-in-ectd-eu-module-1-specification/index.html): EMA's Human Harmonisation Group has reviewed the change requests for the eCTD EU Module 1 Specification. This blog post summarizes their amendments.  (404 words)
- [Webinar: Regulatory Outlook 2026: The Road Ahead for eCTD, IDMP & ePI](/content/events-portal/webinar-regulatory-outlook-2026-the-road-ahead-for-ectd-idmp-ep.html): Webinar: Regulatory Outlook 2026: The Road Ahead for eCTD, IDMP & eP (301 words)
- [Mandatory Use of eCTD for New DMF Submissions in Canada | EXTEDO](/content/blog/mandatory-use-of-ectd-for-new-dmf-submissions-in-canada.html): Health Canada will only accept new Drug Master File (DMF) applications submitted in electronic Common Technical Document (eCTD) format. (418 words)
- [EXTEDO at RAPS Euro Convergence 2024](/content/events-portal/extedo-at-raps-euro-convergence-2024/index.html): Event: RAPS Euro Convergence (338 words)
- [Webinar: The eCTD v4 Upgrade: End-to-End Publishing, Transition & Conversion Services](/content/events-portal/webinar-the-ectd-v4-upgrade-end-to-end-publishing-transition-conversion-services.html): Webinar: The eCTD v4 Upgrade: End-to-End Publishing, Transition & Conversion Services (346 words)
- [RAPS Convergence Long Beach, USA](/content/events/raps-convergence-long-beach-usa/index.html): Event: RAPS US Convergence 2024 (165 words)
- [support/customer-portal-infopage/webinar-asia-ectd-highlights-spotlight-on-chinas-ectd-v4-regional-v1-1-for-china-and-singapore.html](/content/support/customer-portal-infopage/webinar-asia-ectd-highlights-spotlight-on-chinas-ectd-v4-regional-v1-1-for-china-and-singapore.html): Webinar: Asia eCTD Highlights: Spotlight on China's eCTD v4 & Regional v1.1 for China and Singapore (240 words)
- [Webinar: Unlock the Benefits of EXTEDO Training Programs](/content/events/webinar-unlock-the-benefits-of-extedo-training-programs-2026.html): Webinar: Unlock the Benefits of EXTEDO Training Programs (272 words)
- [Meet EXTEDO at GPRAS 2026](/content/events-portal/meet-extedo-at-gpras-2026/index.html): Event: Informa GPRAS - Meet EXTEDO on Site in Brussels! (177 words)
- [Webinar: The EMA eCTD v4  Pilot Explained: Key Concepts, Industry Readiness and Forward Compatibility](/content/events/webinar-the-ema-ectd-v4-pilot-explained-key-concepts-industry-readiness-and-forward-compatibility.html): Webinar: The EMA eCTD v4  Pilot Explained: Key Concepts, Industry Readiness and Forward Compatibility (187 words)
- [footer0/impressum/index.html](/content/footer0/impressum/index.html) (80 words)
- [Event: CPHI Milan 2026: Shaping Pharma's Future](/content/events/event-cphi-milan-2026-shaping-pharmas-future/index.html): Event: CPHI Milan 2026: Shaping Pharma's Future (109 words)
- [support/customer-portal-infopage/powerhouse-collaboration-extedo-teams-up-with-asphalion-at-topra-symposium-2024.html](/content/support/customer-portal-infopage/powerhouse-collaboration-extedo-teams-up-with-asphalion-at-topra-symposium-2024.html): TOPRA Symposium: EXTEDO Teams up with ASPHALION - Visit our booth! (16 words)
- [support/customer-portal-infopage/ai-and-automation-in-pv-boost-your-case-processing-efficiency.html](/content/support/customer-portal-infopage/ai-and-automation-in-pv-boost-your-case-processing-efficiency.html): Webinar: AI and Automation in PV – Boost Your Case Processing Efficiency (16 words)
- [eCTD v4 Masterclass Reloaded - Part II: Learnings & Discussion](/content/events/ectd-v4-masterclass-reloaded-part-ii-learnings-discussion.html): Webinar: eCTD v4 Masterclass Reloaded - Part II: Learnings & Discussion (15 words)
- [eCTD v4 Masterclass Reloaded - Part I: Recap & Update](/content/events-portal/ectd-v4-masterclass-reloaded-part-i-recap-update/index.html): Webinar: eCTD v4 Masterclass Reloaded - Part I: Recap & Update (15 words)
- [eCTD v4.0 Masterclass IV - Document Dynamics: Using the new superpower of eCTD v4.0 documents](/content/events/ectd-v4-0-masterclass-iv-document-dynamics-using-the-new-superpower-of-ectd-v4-0-documents.html): eCTD v4.0 Masterclass IV - Document Dynamics: Using the new superpower of eCTD v4.0 documents (20 words)
- [Webinar: ePI Masterclass - Part VI: Building A Successful ePI Strategy](/content/events/webinar-epi-masterclass-part-vi-building-a-successful-epi-strategy.html): Webinar: ePI Masterclass - Part VI: Building A Successful ePI Strategy  (304 words)
- [Events](/content/events/index.html): Where to meet EXTEDO - in person or online: We are always happy to meet you! (603 words)
- [Pharmacovigilance in a No-Deal Brexit Scenario | EXTEDO](/content/blog/pharmacovigilance-in-a-no-deal-brexit-scenario/index.html): The uncertainty of Brexit and the possibility of a no-deal resolution has left the life sciences industry in a precarious position.  (900 words)
- [eCTD Related Guidelines for US FDA and EU | EXTEDO](/content/blog/ectd-related-guidelines-for-us-fda-and-eu/index.html): With the FDA eCTD mandate for INDs and DMFs, all original applications and lifecycle submissions for human drugs and biologics must be submitted in eCTD. (1,599 words)
- [eDOCSmanager - A secure document management system for life sciences | EXTEDO](/content/software/document-management-hub/edocsmanager/index.html): EXTEDO's eDOCSmanager is a secure document management solution for the effortless management of clinical and regulatory tasks. (564 words)
- [services/business-process-and-regulatory-consulting/ectd-services/index.html](/content/services/business-process-and-regulatory-consulting/ectd-services/index.html): Tailored to the needs of regulatory & related stakeholders, EXTEDO’s business process & regulatory consulting services optimize electronic submission management. (383 words)
- [The Mystery of the EU IG - Insider Perspective | EXTEDO](/content/blog/the-mystery-of-the-eu-ig-insider-perspective/index.html): Anjana Pindoria shares her personal experiences and impressions about the ISO IDMP development and implementation after the release of the EU IG v2.0. (1,032 words)
- [Interview: Meet EXTEDO’s eCTDtemplates! | EXTEDO](/content/blog/interview-meet-extedos-ectdtemplates/index.html): We met EXTEDO's eCTDtemplates for a short interview. They tell us how they support our customers in document creation to reduce time and effort.  (893 words)
- [New Requirements for Electronic Submission of Drug Master Files (DMFs) | EXTEDO](/content/blog/overview-of-the-new-requirements-for-electronic-submission-of-drug-master-files-dmfs.html): Come May 5, 2018, all Drug Master File (DMF) submissions will need to be filed electronically with FDA in an eCTD format, or they will be rejected.  (708 words)
- [DIA Europe 2023](/content/events-portal/dia-europe-2023/index.html): DIA Europe 2023 (34 words)
- [EXTEDO Experts sharing their Expertise - Where to Meet Them | EXTEDO](/content/blog/extedo-experts-sharing-their-expertise-where-to-meet-them.html): Join EXTEDO experts at upcoming events for insights on regulatory compliance and data management. Discover valuable knowledge and networking opportunities. (337 words)
- [The National Health Regulatory Authority in Kingdom of Bahrain chooses EXTEDO´s EURS solution for validation & reviewing | EXTEDO](/content/blog/the-national-health-regulatory-authority-in-kingdom-of-bahrain-chooses-extedos-eurs-solution-for-validation-reviewing.html): The National Health Regulatory Authority in Kingdom of Bahrain chooses EXTEDO´s EURS solution for validation & reviewing (401 words)
- [What are the Differences between eCTD v3 and eCTD v4? - A Comprehensive Guide | EXTEDO](/content/blog/what-are-the-differences-between-ectd-v3-and-ectd-v4-a-comprehensive-guide.html): Discover the key differences between eCTD v3 and v4 to enhance regulatory submissions with improved efficiency, compliance, and document management. (1,162 words)
- [Challenges of Implementing a RIM System](/content/events-portal/challenges-of-implementing-a-rim-system/index.html): Webinar: The Challenges of Implementing a RIM System (11 words)
- [Meet EXTEDO at GPRAS 2026](/content/events/meet-extedo-at-gpras/index.html): Event: Informa GPRAS - Meet EXTEDO on Site in Berlin! (10 words)
- [EU eCTD M1 Specification v3.1.1 and Validation Criteria v8.2 | EXTEDO](/content/blog/eu-ectd-m1-specification-v3-1-1-and-validation-criteria-v8-2-all-changes-in-detail.html): EU eCTD M1 Specification v3.1.1 and Validation Criteria v8.2 – Learn more about all Cchanges in cetail (578 words)
- [Effortless Collaboration – Reduce the complexity of viewing and reviewing in a global organisation](/content/events/complimentary-webinar-effortless-collaboration-reduce-the-complexity-of-viewing-and-reviewing-in-a-global-organisation.html): Effortless Collaboration – Reduce the complexity of viewing and reviewing in a global organisation (150 words)
- [services/business-process-and-regulatory-consulting/pharmacovigilance/index.html](/content/services/business-process-and-regulatory-consulting/pharmacovigilance/index.html): EXTEDO’s Pharmacovigilance business process consulting services are tailored specifically to your needs. Based on many years of experience working hands-on with drug safety rules and regulations, EXTEDO´s team will support you in all aspects of your pharmacovigilance activities. (462 words)
- [WHO goes eCTD - All you need to know | EXTEDO](/content/blog/who-goes-ectd-all-you-need-to-know/index.html): On 13 Nov. 2023, the WHO announced the current timelines for introducing the electronic Common Technical Document (eCTD) format. Find them in our blog. (760 words)
- [5 Ways Cloud-based Computing is Changing Business | EXTEDO](/content/blog/5-ways-cloud-based-computing-is-changing-business/index.html): The cloud revolution is here, and businesses around the world are enjoying the many benefits that cloud-based computing offers. (578 words)
- [Bertelsmann Investments Announces Another Major Investment in the Growing Pharma Tech Market | EXTEDO](/content/blog/bertelsmann-investments-announces-another-major-investment-in-the-growing-pharma-tech-market.html): Bertelsmann Investments (BI) is acquiring the pharma tech company EXTEDO from European technology company IABG. This acquisition presents a fantastic opportunity for EXTEDO to leverage the strengths and resources of the Bertelsmann Group, further enhancing our capabilities and expanding our global reach. (824 words)
- [The Challenges of Implementing a Regulatory Information Management (RIM) System | EXTEDO](/content/blog/the-challenges-of-implementing-a-regulatory-information-management-rim-system.html): Where are the challenges in RIM Implementation? We describe what to think of before, during, and after implementing a Regulatory Management System.  (1,168 words)
- [Agency Masterclass eCTD v4 - Part I: Speak Easy - Discover the New Language of eCTD v4](/content/events-portal/agency-masterclass-ectd-v4-part-i-speak-easy-discover-the-new-language-of-ectd-v4.html): Webinar: Agency Masterclass eCTD v4 - Part I: Speak Easy - Discover the New Language of eCTD v4 (302 words)
- [Why we believe in IDMP, and you should too | EXTEDO](/content/blog/why-we-believe-in-idmp-and-you-should-too/index.html): The EMA announced that it will delay the roll-out of the new ISO IDMP standard within Europe until after the completion of the formal Brexit processes.  (773 words)
- [The Nitty Gritty Details of Regulatory Submission Publishing](/content/events/the-nitty-gritty-details-of-regulatory-submission-publishing.html): Webinar: The Nitty Gritty Details of Regulatory Submission Publishing (39 words)
- [What is eCTD 4.0? | EXTEDO](/content/blog/what-is-ectd-4-0.html): eCTD 4.0, the upcoming new version of eCTD, will offer new capabilities for regulatory affairs. We explain what eCTD 4.0 actually stands for.  (369 words)
- [Agency Masterclass eCTD v4 - Part I: Speak Easy - Discover the New Language of eCTD v4](/content/events/agency-masterclass-ectd-v4-part-i-speak-easy-discover-the-new-language-of-ectd-v4.html): Webinar: Agency Masterclass eCTD v4 - Part I: Speak Easy - Discover the New Language of eCTD v4 (345 words)
- [The Drivers and Benefits behind eCTD 4.0 | EXTEDO](/content/blog/the-drivers-and-benefits-behind-ectd-4-0.html): In recent years, a lot has happened surrounding the development and evolution of the eCTD standard. (968 words)
- [DIA Regulatory Submissions, Information, and Document Management Forum 2026](/content/events-portal/dia-regulatory-submissions-information-and-document-management-forum-2026.html): Event: EXTEDO at DIA RSIDM Forum 2026 (297 words)
- [RAPS Convergence Long Beach, USA](/content/events-portal/raps-convergence-long-beach-usa/index.html): Event: RAPS US Convergence 2024 (175 words)
- [Glossary of Regulatory Abbreviations | EXTEDO](/content/blog/glossary-of-regulatory-abbreviations/index.html): Navigate the maze of regulatory abbreviations with our Glossary, which is regularly updated to provide all the relevant information. (262 words)
- [support/customer-portal-infopage/webinar-ectd-compliant-templates-blueprints-for-success.html](/content/support/customer-portal-infopage/webinar-ectd-compliant-templates-blueprints-for-success.html): Webinar: eCTD-Compliant Templates: Blueprints for Success (236 words)
- [support/customer-portal-infopage/from-metadata-to-multilingual-insights-the-ai-powered-future-of-rim.html](/content/support/customer-portal-infopage/from-metadata-to-multilingual-insights-the-ai-powered-future-of-rim.html): Webinar: From Metadata to Multilingual Insights: The AI-Powered Future of RIM (178 words)
- [Generis Generate 2024](/content/events-portal/generis-generate-2024/index.html): Generis Generate: Visit our booth! (34 words)
- [Webinar: Navigate Egypt’s Digital Shift to eCTD for Regulatory Submissions](/content/events-portal/webinar-navigate-egypts-digital-shift-to-ectd-for-regulatory-submissions.html): Webinar: Navigate Egypt’s Digital Shift to eCTD for Regulatory Submissions (164 words)
- [EXTEDO Innovation Days & User Group Meetings replaced by virtual meetings | EXTEDO](/content/blog/extedo-innovation-days-user-group-meetings-replaced-by-virtual-meetings.html): EXTEDO Innovation Days & User Group Meetings replaced by virtual meetings (208 words)
- [Key Concepts Behind eCTD 4.0 and their Impact on Product Submissions | EXTEDO](/content/blog/key-concepts-behind-ectd-4-0-and-their-impact-on-product-submissions.html): eCTD 4.0 has a variety of new terminology. Some of these terms are just new words for old concepts, while others are completely new to the eCTD world. (1,582 words)
- [support/customer-portal-infopage/webinar-china-ectd-v1-1-unpacked-the-real-impact-of-the-2026-update.html](/content/support/customer-portal-infopage/webinar-china-ectd-v1-1-unpacked-the-real-impact-of-the-2026-update.html): Webinar: China eCTD v1.1 Unpacked: The Real Impact of the 2026 Update (231 words)
- [Webinar: Unlock the Benefits of EXTEDO Training Programs](/content/events-portal/webinar-unlock-the-benefits-of-extedo-training-programs0325.html): Webinar: Unlock the Benefits of EXTEDO Training Programs (219 words)
- [Webinar: Smart Quality: How AI transforms your eQMS](/content/events/webinar-smart-quality-how-ai-transforms-your-eqms/index.html): Webinar: Smart Quality: How AI transforms your eQMS (190 words)
- [Webinar: Quality Unlocked: How to create a QMS masterpiece](/content/events/webinar-quality-unlocked-how-to-create-a-qms-masterpiece.html): Webinar: Quality Unlocked: How to create a QMS masterpiece (14 words)
- [Updated Version of the HMA eSubmission Roadmap (v2.2) Available | EXTEDO](/content/blog/updated-version-of-the-hma-esubmission-roadmap-v2-2-available.html): The final version of the HMA eSubmission roadmap has been updated on 21 June 2019.
 (138 words)
- [support/customer-portal-infopage/world-patient-safety-congress-americas-2026/index.html](/content/support/customer-portal-infopage/world-patient-safety-congress-americas-2026/index.html): Event: World Patient Safety Congress Americas 2026 (141 words)
- [The Move to the Cloud - All about EXTEDO Hosting](/content/events-portal/the-move-to-the-cloud-all-about-extedo-hosting/index.html): Webinar: The Move to the Cloud - All about EXTEDO Hosting (354 words)
- [support/customer-portal-infopage/navigating-from-ctd-to-ectd-a-comprehensive-two-day-workshop-for-brazil-day-2.html](/content/support/customer-portal-infopage/navigating-from-ctd-to-ectd-a-comprehensive-two-day-workshop-for-brazil-day-2.html): Webinar: Navigating from CTD to eCTD: A Comprehensive Two-Day Workshop for Brazil, Day II  (704 words)
- [eCTD v4.0 Masterclass III - Mastering Meta: Exploring eCTD v4.0's CVs and IDs](/content/events-portal/ectd-v4-0-masterclass-iii-mastering-mastering-meta-exploring-ectd-v4-0s-cvs-and-ids.html): eCTD v4.0 Masterclass III - Mastering Meta: Exploring eCTD v4.0's CVs and IDs (18 words)
- [Forum Institute Seminar: eCTD Essentials Overview](/content/events-portal/forum-institute-seminar-ectd-essentials-overview/index.html): Forum Institute Seminar: eCTD Essentials Overview (11 words)
- [Gens & Associates IDMP Vendor Assessment & Capability Survey - How does MPDmanager powered by CARA compare to competing products? | EXTEDO](/content/blog/gens-associates-idmp-vendor-assessment-capability-survey-how-does-mpdmanager-powered-by-cara-compare-to-competing-products.html): Gens & Associates IDMP Vendor Assessment & Capability Survey - How does MPDmanager powered by CARA compare to competing products? (507 words)
- [GCC Regulatory Affairs Pharma Summit 2025](/content/events/gcc-regulatory-affairs-pharma-summit-2025/index.html): GCC Regulatory Affairs Pharma Summit 2025 (11 words)
- [Webinar: Mastering eCTD v4.0: Get Your Questions Answered!](/content/events/webinar-mastering-ectd-v4-0-get-your-questions-answered.html): Webinar: Mastering eCTD v4.0: Get Your Questions Answered! (13 words)
- [solutions-for-regulatory-agencies/index.html](/content/solutions-for-regulatory-agencies/index.html): EXTEDO is the provider of choice for more than 35 regulatory authorities, offering them software and service solutions to optimize their processes. (381 words)
- [services/extended-support-services/index.html](/content/services/extended-support-services/index.html): EXTEDO Extended Support Services allow you to extend your customer support outside of regular working hours. (489 words)
- [EU - ASMF and adding new countries in established ASMFs as series with CA, USA, ZA](/content/events-portal/complimentary-webinar-eu-asmf-and-adding-new-countries-in-established-asmfs-as-series-with-ca-usa-za.html): EU - ASMF and adding new countries in established ASMFs as series with CA, USA, ZA (156 words)
- [What is eCTD? - The story of the electronic Common Technical Document | EXTEDO](/content/blog/what-is-ectd-the-story-of-electronic-common-technical-document.html): What is eCTD? - We introduce the history of the electronic Common Technical Document (eCTD) to you. (467 words)
- [Info Market: Digital RA & QM-Solutions](/content/events/info-market-digital-ra-qm-solutions/index.html): Info Market: Digital RA & QM-Solutions (51 words)
- [Powerhouse Collaboration: EXTEDO Teams Up with ASPHALION at TOPRA Symposium 2024!](/content/events/powerhouse-collaboration-extedo-teams-up-with-asphalion-at-topra-symposium-2024.html): TOPRA Symposium: EXTEDO Teams up with ASPHALION - Visit our booth! (16 words)
- [eCTD v4.0  Masterclass I - Speak Easy: Discover the New Language of eCTD v4.0](/content/events-portal/ectd-v4-0-masterclass-i-speak-easy-discover-the-new-language-of-ectd-v4-0.html): eCTD v4.0  Masterclass I - Speak Easy: Discover the New Language of eCTD v4.0 (19 words)
- [Webinar: Regulatory Outlook 2026: The Road Ahead for eCTD, IDMP & ePI](/content/events/webinar-regulatory-outlook-2026-the-road-ahead-for-ectd-idmp-ep.html): Webinar: Regulatory Outlook 2026: The Road Ahead for eCTD, IDMP & eP (299 words)
- [Webinar: Global Implementation of eCTD, ePI, and IDMP: Insights, Strategies & Live Demo](/content/events/webinar-global-implementation-of-ectd-epi-and-idmp-insights-strategies-live-demo.html): Webinar: Global Implementation of eCTD, ePI, and IDMP: Insights, Strategies & Live Demo (258 words)
- [support/index.html](/content/support/index.html): Are you looking for support regarding your EXTEDO products or the latest validation sets? Whatever you need, our support team is here to help you.. (304 words)
- [Webinar: Egypt's New eCTD Framework](/content/events/webinar-egypts-new-ectd-framework/index.html): Webinar: Egypt's New eCTD Framework- Egypt's New eCTD Framework  Understanding the New EDA Requirements and Preparing for Compliance (36 words)
- [US FDA Adverse Event Reporting System (FAERS) Electronic Submissions | EXTEDO](/content/blog/us-fda-adverse-event-reporting-system-faers-electronic-submissions.html): FDA finalized their E2B(R3) guidelines for submitting safety reports. The FDA webpage was updated to include technical files and the finalized guidelines. (338 words)
- [Updates on EMA Electronic Application Management](/content/events/updates-on-ema-electronic-application-management/index.html): Updates on EMA Electronic Application Management - Implications of ISO IDMP in regulatory processes (PLM, CTIS, IRIS) (11 words)
- [European eCTD Module 1 v3.0: What to expect & how to prepare? | EXTEDO](/content/blog/european-ectd-module-1-v3-0-what-to-expect-how-to-prepare.html): European eCTD Module 1 v3.0: What to expect & how to prepare? (289 words)
- [GCC Regulatory Affairs Pharma Summit](/content/events-portal/gcc-regulatory-affairs-pharma-summit/index.html): GCC Regulatory Affairs Pharma Summit (10 words)
- [DIA Europe 2025](/content/events/dia-europe-2025/index.html): DIA Europe 2025: Meet the EXTEDO team (208 words)
- [Updated notification method for QPPV and PSMF updates to MHRA (Replacing eCTD sequence submission requirement) | EXTEDO](/content/blog/updated-notification-method-for-qppv-and-psmf-updates-to-mhrareplacing-ectd-sequence-submission-requirement.html): The MHRA recently issued new guidelines outlining the steps for making specific changes to medical products. (436 words)
- [support/customer-portal-infopage/webinar-audit-readiness-in-the-digital-age-of-life-sciences-part-i.html](/content/support/customer-portal-infopage/webinar-audit-readiness-in-the-digital-age-of-life-sciences-part-i.html): Webinar: Audit Readiness in the Digital Age of Life Sciences - Part I (18 words)
- [Webinar: Evolution of Structured Data Submissions](/content/events-portal/webinar-evolution-of-structured-data-submissions/index.html): TOPRA Webinar: Evolution of Structured Data Submissions (with Asphalion) (215 words)
- [Webinar: The Tiny but Mighty Differences of DMF Submissions: US FDA vs Health Canada](/content/events/webinar-the-tiny-but-mighty-differences-of-dmf-submissions-us-fda-vs-health-canada.html): Webinar: The Tiny but Mighty Differences of DMF Submissions: US FDA vs Health Canada (19 words)
- [Submission Platforms in EU and Further Changes | EXTEDO](/content/blog/submission-platforms-in-eu-and-further-changes/index.html): The EMA and the 32 national competent authorities in Europe are almost at the finishing line of the race to complete the switch to eCTD submissions.  (691 words)
- [Webinar: Revolutionizing Regulatory Publishing – eCTD v4 Meets Structured Content and AI](/content/events-portal/webinar-revolutionizing-regulatory-publishing-ectd-v4-meets-structured-content-and-ai.html): Webinar: Revolutionizing Regulatory Publishing – eCTD v4 Meets Structured Content and AI (333 words)
- [support/customer-portal-infopage/webinar-from-draft-to-signed-regulatory-document-management-with-extedopulse-infocert-sign.html](/content/support/customer-portal-infopage/webinar-from-draft-to-signed-regulatory-document-management-with-extedopulse-infocert-sign.html): Webinar: From Draft to Signed: Regulatory Document Management with EXTEDOpulse & Infocert Sign (18 words)
- [Meet EXTEDO at GPRAS 2026](/content/events/meet-extedo-at-gpras-2026/index.html): Event: Informa GPRAS - Meet EXTEDO on Site in Brussels! (175 words)
- [The European Medicines Agency (EMA) comes to Amsterdam | EXTEDO](/content/blog/the-european-medicines-agency-ema-comes-to-amsterdam.html): The European Medicines Agency (EMA) is coming to Amsterdam. The Dutch bid won a draw from Milan, the only remaining candidate after three rounds.  (425 words)
- [EXTEDO at AfriSummit 2024](/content/events-portal/extedo-at-afrisummit-2024/index.html): PharmaReg AfriSummit (9 words)
- [TOPRA Symposium 2023](/content/events/topra-symposium-2023/index.html): TOPRA Symposium 2023 (199 words)
- [EXTEDO Opens New Office in Shanghai | EXTEDO](/content/blog/extedo-opens-new-office-in-shanghai/index.html): EXTEDO Opens New Office in Shanghai (352 words)
- [support/customer-portal-infopage/topra-symposium-2023/index.html](/content/support/customer-portal-infopage/topra-symposium-2023/index.html): TOPRA Symposium 2023 (197 words)
- [EMA PMS Info Day 2026: The Future of Data-Driven Medicines Regulation in Europe | EXTEDO](/content/blog/ema-pms-info-day-2026-the-future-of-data-driven-medicines-regulation-in-europe.html): Discover the EMA's shift to data-driven medicines regulation by 2029 with PMS, emphasizing data quality, API integration, and collaboration. (380 words)
- [Moving Forward with IDMP](/content/events/moving-forward-with-idmp/index.html): Webinar: Moving Forward With IDMP (9 words)
- [support/customer-portal-infopage/webinar-spot-the-differences-practical-nuances-in-ema-vs-us-fda-ectd-v4.html](/content/support/customer-portal-infopage/webinar-spot-the-differences-practical-nuances-in-ema-vs-us-fda-ectd-v4.html): Webinar: Spot the Differences: Practical Nuances in EMA vs. US FDA eCTD v4 (231 words)
- [US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B(R3) Standards | EXTEDO](/content/blog/us-fda-adopts-ich-clinical-trials-guideline-with-exclusive-reference-to-e2b-r3-standards.html): The US FDA announced, that they have adopted the ICH E8(R1) Harmonised Guideline on General Considerations for Clinical Studies. (319 words)
- [support/customer-portal-infopage/webinar-epi-masterclass-part-iv-the-overall-impact-of-epi.html](/content/support/customer-portal-infopage/webinar-epi-masterclass-part-iv-the-overall-impact-of-epi.html): Webinar: ePI Masterclass - Part IV: The Overall Impact of ePI  (491 words)
- [GCC Regulatory Affairs Pharma Summit 2024](/content/events-portal/gcc-regulatory-affairs-pharma-summit-2024/index.html): GCC Pharma Summit: Meet the EXTEDO team! (11 words)
- [eSubmission - Your To-dos 2023 Assistance for Your Submission and Data Management in Regulatory Affairs](/content/events-portal/forum-institut-esubmission-your-todos-2023/index.html): Seminar: eSubmission - Your To-dos 2023  (20 words)
- [Webinar: EXTEDO’s Technical Account Management Services: Delivering Strategic Value Through Collaboration](/content/events-portal/webinar-extedos-technical-account-management-services-delivering-strategic-value-through-collaboration.html): Webinar: EXTEDO’s Technical Account Management Services: Delivering Strategic Value Through Collaboration (313 words)
- [support/customer-portal-infopage/forum-event-these-xevmpd-data-must-now-be-updated-for-pms.html](/content/support/customer-portal-infopage/forum-event-these-xevmpd-data-must-now-be-updated-for-pms.html): FORUM Event: These XEVMPD data must now be updated for PMS (243 words)
- [support/customer-portal-infopage/index.html](/content/support/customer-portal-infopage/index.html) (638 words)
- [Effortless Collaboration – Reduce the complexity of viewing and reviewing in a global organisation](/content/events-portal/complimentary-webinar-effortless-collaboration-reduce-the-complexity-of-viewing-and-reviewing-in-a-global-organisation.html): Effortless Collaboration – Reduce the complexity of viewing and reviewing in a global organisation (151 words)
- [support/customer-portal-infopage/world-patient-safety-congress/index.html](/content/support/customer-portal-infopage/world-patient-safety-congress/index.html): Event: World Patient Safety Congress (132 words)
- [DIA Regulatory Submissions, Information, and Document Management Forum 2025](/content/events-portal/dia-regulatory-submissions-information-and-document-management-forum-2025.html): DIA Regulatory Submissions, Information, and Document Management Forum 2025 (214 words)
- [EXTEDO上海分公司成立！ | EXTEDO](/content/blog/extedo-e4-b8-8a-e6-b5-b7-e5-88-86-e5-85-ac-e5-8f-b8-e6-88-90-e7-ab-8b.html): EXTEDO上海分公司成立！ (42 words)
- [How to Outsource Your eCTD Submission Publishing: What to Look for in a Vendor | EXTEDO](/content/blog/how-to-outsource-your-ectd-submission-publishing-what-to-look-for-in-a-vendor.html): Learn how to effectively outsource your eCTD submission publishing by selecting the right vendor to enhance expertise, flexibility, and reduce risks for your regulatory needs. (1,288 words)
- [eCTD v4.0 Masterclass V - Seamless Transition: Balancing eCTD v3.2 Present with v4.0 Future](/content/events/ectd-v4-0-masterclass-v-seamless-transition-balancing-ectd-v3-2-present-with-v4-0-future.html): eCTD v4.0 Masterclass V - Seamless Transition: Balancing eCTD v3.2 Present with v4.0 Future (19 words)
- [Webinar: Structured Content, Managed Data, & AI - How to Build New Ways for Regulated Information](/content/events/webinar-structured-content-managed-data-ai-how-to-build-new-ways-for-regulated-information.html): Webinar: Structured Content, Managed Data, & AI - How to Build New Ways for Regulated Information (156 words)
- [EMA's December Updates Unwrapped! | EXTEDO](/content/blog/emas-december-updates-unwrapped/index.html): EMA publishes three updates in december 2024 - find them here! (339 words)
- [End-to-End Management of Regulatory Processes and Digital Trust in the Drug Lifecycle](/content/events-portal/end-to-end-management-of-regulatory-processes-and-digital-trust-in-the-drug-lifecycle.html): Webinar: End-to-End Management of Regulatory Processes and Digital Trust in the Drug Lifecycle (17 words)
- [End-2-End with EXTEDOpulse:  Automate Your Regulatory Processes for Effortless Compliance](/content/events-portal/end-2-end-with-extedopulse-automate-your-regulatory-processes-for-effortless-compliance.html): End-2-End with EXTEDOpulse:  Automate Your Regulatory Processes for Effortless Compliance (15 words)
- [Webinar: Smart Quality: How AI transforms your eQMS](/content/events-portal/webinar-smart-quality-how-ai-transforms-your-eqms/index.html): Webinar: Smart Quality: How AI transforms your eQMS (222 words)
- [support/customer-portal-infopage/dia-europe-2024/index.html](/content/support/customer-portal-infopage/dia-europe-2024/index.html): DIA Europe: Meet the EXTEDO team (8 words)
- [EXTEDO & Wrike announce strategic partnership to release a planning and tracking solution for the life sciences industry | EXTEDO](/content/blog/extedo-wrike-announce-strategic-partnership-to-release-a-planning-and-tracking-solution-for-the-life-sciences-industry.html): EXTEDO & Wrike announce strategic partnership to release a planning and tracking solution for the life sciences industry (521 words)
- [Ready, set, go! A practical guide to empower your organization with a Quality Management System](/content/events-portal/ready-set-go-a-practical-guide-to-empower-your-organization-with-a-quality-management-system.html): Ready, set, go! A practical guide to empower your organization with a Quality Management System (20 words)
- [support/customer-portal-infopage/webinar-navigating-regulatory-changes-singapores-ectd-birth-australias-module-1-v3-2-update.html](/content/support/customer-portal-infopage/webinar-navigating-regulatory-changes-singapores-ectd-birth-australias-module-1-v3-2-update.html): Webinar: Navigating Regulatory Changes: Singapore’s eCTD Birth & Australia’s Module 1 v3.2 Update (153 words)
- [support/customer-portal-infopage/challenges-of-implementing-a-rim-system/index.html](/content/support/customer-portal-infopage/challenges-of-implementing-a-rim-system/index.html): Webinar: The Challenges of Implementing a RIM System (11 words)
- [DIA China Annual Meeting 2025](/content/events/dia-china-annual-meeting-2025/index.html): EXTEDO at DIA China Annual Meeting 2025 (36 words)
- [Forum Institute Seminar: eCTD Essentials Overview](/content/events/forum-institute-seminar-ectd-essentials-overview/index.html): Forum Institute Seminar: eCTD Essentials Overview (11 words)
- [Webinar: Egypt's New eCTD Framework](/content/events-portal/webinar-egypts-new-ectd-framework/index.html): Webinar: Egypt's New eCTD Framework- Egypt's New eCTD Framework  Understanding the New EDA Requirements and Preparing for Compliance (10 words)
- [GCC Regulatory Affairs Pharma Summit 2026](/content/events/gcc-regulatory-affairs-pharma-summit-2026/index.html): Event: GCC Regulatory Affairs Pharma Summit 2026 (11 words)
- [support/customer-portal-infopage/dia-regulatory-submissions-information-and-document-management-forum.html](/content/support/customer-portal-infopage/dia-regulatory-submissions-information-and-document-management-forum.html): DIA Regulatory Submissions, Information, and Document Management Forum 2024 (14 words)
- [EXTEDO at AfriSummit 2026](/content/events/extedo-at-afrisummit-2026/index.html): Event: PharmaReg AfriSummit (213 words)
- [EXTEDO at AfriSummit 2024](/content/events/extedo-at-afrisummit-2024/index.html): PharmaReg AfriSummit (9 words)
- [eCTD v4.0 Masterclass III - Mastering Meta: Exploring eCTD v4.0's CVs and IDs](/content/events/ectd-v4-0-masterclass-iii-mastering-mastering-meta-exploring-ectd-v4-0s-cvs-and-ids.html): eCTD v4.0 Masterclass III - Mastering Meta: Exploring eCTD v4.0's CVs and IDs (18 words)
- [software/submission-management-hub/index.html](/content/software/submission-management-hub/index.html): The Submission Management Hub allows you to publish, validate, view, and review eCTD and other regulatory submissions globally with effortless compliance.  (224 words)
- [New Guidance on Handling of DCP/MRP | EXTEDO](/content/blog/new-guidance-on-handling-of-dcp/mrp/index.html): MHRA published new Guidance on handling of DCP/MRP Procedures from 1st January 2021 on. (416 words)
- [Webinar: Training on eCTD in Tunisia - Basics of electronic submissions and Tunisian Regional eCTD M1](/content/events/webinar-training-on-ectd-in-tunisia-basics-of-electronic-submissions-and-tunisian-regional-ectd-m1.html): Webinar: Training on eCTD in Tunisia - Basics of electronic submissions and Tunisian Regional eCTD M1 (20 words)
- [EU IDMP Implementation Guide Version 1 Released | EXTEDO](/content/blog/eu-idmp-implementation-guide-version-1-released/index.html): The EMA has published version 1 of the EU IDMP Implementation Guide with specification, data elements, and business rules for the implementation of ISO IDMP (357 words)
- [Webinar: ePI Masterclass - Part IV: The Overall Impact of ePI](/content/events/webinar-epi-masterclass-part-iv-the-overall-impact-of-epi.html): Webinar: ePI Masterclass - Part IV: The Overall Impact of ePI  (461 words)
- [Webinar: EXTEDO’s Technical Account Management Services: Delivering Strategic Value Through Collaboration](/content/events/webinar-extedos-technical-account-management-services-delivering-strategic-value-through-collaboration.html): Webinar: EXTEDO’s Technical Account Management Services: Delivering Strategic Value Through Collaboration (329 words)
- [Introduction to CTD, NeeS, and eCTD for the Egyptian Pharmaceutical Industry – live demo by EXTEDO](/content/events-portal/introduction-to-ctd-nees-and-ectd-for-the-egyptian-pharmaceutical-industry-live-demo-by-extedo.html): Webinar: Introduction to CTD, NeeS, and eCTD for the Egyptian Pharmaceutical Industry – live demo by EXTEDO (16 words)
- [RAPS Webinar: RIM - The data foundation your compliance strategy depends on](/content/events-portal/raps-webinar-rim-the-data-foundation-your-compliance-strategy-depends-on.html): RAPS Webinar with InnovX: RIM - The data foundation your compliance strategy depends on (328 words)
- [New EU General Data Protection Regulation (GDPR) | EXTEDO](/content/blog/new-eu-general-data-protection-regulation-gdpr/index.html): New EU General Data Protection Regulation (GDPR) (1,277 words)
- [PharmaReg & MedDevReg AfriSummit](/content/events/pharmareg-meddevreg-afrisummit/index.html): PharmaReg AfriSummit (9 words)
- [GCC Regulatory Affairs Pharma Summit 2024](/content/events/gcc-regulatory-affairs-pharma-summit-2024/index.html): GCC Pharma Summit: Meet the EXTEDO team! (11 words)
- [EXTEDO Announces New Regional Partnership with Inpharmatis for the Baltic and CIS region | EXTEDO](/content/blog/extedo-announces-new-regional-partnership-with-inpharmatis-for-the-baltic-and-cis-region.html): EXTEDO Announces New Regional Partnership with Inpharmatis for the Baltic and CIS region (295 words)
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- [Webinar: eCTD-Compliant Templates: Blueprints for Success](/content/events-portal/webinar-ectd-compliant-templates-blueprints-for-success.html): Webinar: eCTD-Compliant Templates: Blueprints for Success (235 words)
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- [Ready, set, go! A practical guide to empower your organization with a Quality Management System](/content/events/ready-set-go-a-practical-guide-to-empower-your-organization-with-a-quality-management-system.html): Ready, set, go! A practical guide to empower your organization with a Quality Management System (15 words)
- [EU Medical Device Regulation 2020 - What You Need to Know | EXTEDO](/content/blog/eu-medical-device-regulation-2020-what-you-need-to-know.html): Businesses need to comply with the new EU Medical Device Regulation and the EU In-vitro Diagnostics Devices Regulation passed by the European Parliament.  (1,150 words)
- [TOPRA Symposium 2025](/content/events/topra-symposium-2025/index.html): Event: TOPRA Symposium 2025 (8 words)
- [3 Vital Cloud Migration Considerations | EXTEDO](/content/blog/3-vital-cloud-migration-considerations/index.html): As a company in the life sciences industry, you may consider cloud-based computing and how best to migrate your current business processes to the cloud. (802 words)
- [Webinar: EXTEDO Customer Success Series: ​ REIG JOFRE’s Path to IDMP Readiness](/content/events/webinar-extedo-customer-success-series-reig-jofres-path-to-idmp-readiness.html): Webinar: EXTEDO Customer Success Series: ​REIG JOFRE’s Path to IDMP Readiness (183 words)
- [Webinar: ePI Masterclass - Part V: How to Prepare For ePI](/content/events/webinar-epi-masterclass-part-v-how-to-prepare-for-epi.html): Webinar: ePI Masterclass - Part V: How to Prepare For ePI (304 words)
- [support/customer-portal-infopage/2nd-annual-pharmaceutical-regulatory-affairs-summit.html](/content/support/customer-portal-infopage/2nd-annual-pharmaceutical-regulatory-affairs-summit.html): 2nd Annual Pharmaceutical Regulatory Affairs Summit (155 words)
- [Webinar: Regulatory Priorities: Essential To-Dos and Timelines for PMS, ESMP, and More](/content/events-portal/webinar-regulatory-priorities-essential-to-dos-and-timelines-for-pms-esmp-and-more.html): Webinar: Regulatory Priorities: Essential To-Dos and Timelines for PMS, ESMP, and More (17 words)
- [support/customer-portal-infopage/ectd-v4-0-masterclass-i-speak-easy-discover-the-new-language-of-ectd-v4-0.html](/content/support/customer-portal-infopage/ectd-v4-0-masterclass-i-speak-easy-discover-the-new-language-of-ectd-v4-0.html): eCTD v4.0  Masterclass I - Speak Easy: Discover the New Language of eCTD v4.0 (19 words)
- [eCTD v4: Understanding the New Language of Regulatory Submissions | EXTEDO](/content/blog/ectd-v4-understanding-the-new-language-of-regulatory-submissions.html): Discover the essential terminology changes in eCTD v4, enhancing regulatory submissions with improved structure and efficiency for better lifecycle management. (781 words)
- [FORUM Event: These XEVMPD data must now be updated for PMS](/content/events-portal/forum-event-these-xevmpd-data-must-now-be-updated-for-pms.html): FORUM Event: These XEVMPD data must now be updated for PMS (243 words)
- [Introduction to CTD, NeeS, and eCTD for the Egyptian Pharmaceutical Industry – live demo by EXTEDO](/content/events/introduction-to-ctd-nees-and-ectd-for-the-egyptian-pharmaceutical-industry-live-demo-by-extedo.html): Webinar: Introduction to CTD, NeeS, and eCTD for the Egyptian Pharmaceutical Industry – live demo by EXTEDO (16 words)
- [eCTD v4.0 Masterclass II - Architecture of Change: The Structure of eCTD v4.0](/content/events/ectd-v4-0-masterclass-ii-architecture-of-change-the-structure-of-ectd-v4-0.html): eCTD v4.0 Masterclass II - Architecture of Change: The Structure of eCTD v4.0 (18 words)
- [ePI Summit 2023](/content/events-portal/epi-summit-2023/index.html): ePI Summit 2023  (8 words)
- [DIA 2025 Global Annual](/content/events/dia-2025-global-annual/index.html): EXTEDO at DIA Global Annual 2025 – Empowering Life Sciences with cormeo at Booth #825! (9 words)
- [The Sticky Note of Regulatory Compliance: Why STFs Still Matter | EXTEDO](/content/blog/the-sticky-note-of-regulatory-compliance-why-stfs-still-matter.html): Discover the importance of Study Tagging Files (STFs) in regulatory compliance and how they enhance data utilization and review efficiency for FDA submissions. (737 words)
- [Webinar: From Confusion to Control - Master Data Management in EXTEDOpulse powered by CARA](/content/events/webinar-from-confusion-to-control-master-data-management-in-extedopulse-powered-by-cara.html): Webinar: From Confusion to Control - Master Data Management in EXTEDOpulse powered by CARA (19 words)
- [Webinar: ePI Masterclass - Part III: What ePI Means for Each Stakeholder](/content/events/webinar-epi-masterclass-part-iii-what-epi-means-for-each-stakeholder.html): Webinar: ePI Masterclass - Part III: What ePI Means for Each Stakeholder (403 words)
- [Webinar: ePI Masterclass - Part I: Why ePI matters, and when you need to be ready](/content/events/webinar-epi-masterclass-parti-why-epi-matters-and-when-you-need-to-be-ready.html): Webinar: ePI Masterclass - Part I: Why ePI matters, and when you need to be ready (279 words)
- [Australia readies itself for eCTD only | EXTEDO](/content/blog/australia-readies-itself-for-ectd-only/index.html): Starting on the 1st November, Australia’s TGA will begin a staged transition for all prescription medicine to eCTD format only. (205 words)
- [Webinar: At The Pulse Of Your Data: Introducing RIMS To Harmonize Digital Heartbeats](/content/events-portal/webinar-at-the-pulse-of-your-data-introducing-rims-to-harmonize-digital-heartbeats.html): Webinar: At The Pulse Of Your Data: Introducing RIMS To Harmonize Digital Heartbeats (18 words)
- [Webinar: Recap of the ePI Summit 2026 – Key Updates, Insights & Next Steps](/content/events/webinar-recap-of-the-epi-summit-2026-key-updates-insights-next-steps.html): Webinar: Recap of the ePI Summit 2026 – Key Updates, Insights & Next Steps (335 words)
- [EMA Publishes New Timeline For DADI Project | EXTEDO](/content/blog/ema-publishes-new-timeline-for-dadi-project/index.html): The European Medicines Agency (EMA) updated the timeline for the IDMP DADI project on 24 May 2022.  (332 words)
- [AI and Automation in PV – Boost Your Case Processing Efficiency](/content/events/ai-and-automation-in-pv-boost-your-case-processing-efficiency.html): Webinar: AI and Automation in PV – Boost Your Case Processing Efficiency (16 words)
- [support/customer-portal-infopage/pharmacovigilance-world-2026-0/index.html](/content/support/customer-portal-infopage/pharmacovigilance-world-2026-0/index.html): Event: Pharmacovigilance World 2026: Meet the EXTEDO team (146 words)
- [Moving Forward with IDMP](/content/events-portal/moving-forward-with-idmp/index.html): Webinar: Moving Forward With IDMP (9 words)
- [Egyptian Drug Authority Moves Forward with Digital Transformation: Phase II Agreement Signed with EXTEDO and DAF | EXTEDO](/content/blog/egyptian-drug-authority-moves-forward-with-digital-transformation-phase-ii-with-extedo.html): Egyptian Drug Authority Moves Forward with Digital Transformation: Phase II Agreement Signed with EXTEDO and DAF (553 words)
- [support/customer-portal-infopage/lets-illuminate-the-future-of-healthcare-at-dia-global-annual-meeting-2024-with-extedo.html](/content/support/customer-portal-infopage/lets-illuminate-the-future-of-healthcare-at-dia-global-annual-meeting-2024-with-extedo.html): DIA Global Annual Meeting: Visit our booth! (19 words)
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- [Validation – Part II: Validation Criteria in Regulatory Processes | EXTEDO](/content/blog/validation-criteria-in-regulatory-processes/index.html): Learn more about the role of Validation criteria in regulatory processes  - how they are defined and why they differ all around the world.  (538 words)
- [Webinar: China eCTD v1.1 Unpacked: The Real Impact of the 2026 Update](/content/events/webinar-china-ectd-v1-1-unpacked-the-real-impact-of-the-2026-update.html): Webinar: China eCTD v1.1 Unpacked: The Real Impact of the 2026 Update (231 words)
- [support/customer-portal-infopage/info-market-digital-ra-qm-solutions/index.html](/content/support/customer-portal-infopage/info-market-digital-ra-qm-solutions/index.html): Info Market: Digital RA & QM-Solutions (11 words)
- [Agency Masterclass eCTD v4 - Part VI: Scan the Next Era - Navigating Tomorrow's eCTD Submissions](/content/events-portal/agency-masterclass-ectd-v4-part-vi-scan-the-next-era-navigating-tomorrows-ectd-submissions.html): Webinar: Agency Masterclass eCTD v4 - Part VI: Scan the Next Era - Navigating Tomorrow's eCTD Submissions (235 words)
- [What is IDMP? | EXTEDO](/content/blog/introduction-to-iso-idmp/index.html): Starting from next year, companies that have pharmaceutical products registered within the EU will need to comply with the new IDMP standard.  (569 words)
- [support/customer-portal-infopage/dia-europe-2026/index.html](/content/support/customer-portal-infopage/dia-europe-2026/index.html): Event: DIA Europe 2026 - Meet the EXTEDO team! (194 words)
- [TOPRA Symposium 2023](/content/events-portal/topra-symposium-2023/index.html): TOPRA Symposium 2023 (196 words)
- [Digital Management of Data and Documents, speeding up your daily business process](/content/events-portal/digital-management-of-data-and-documents-speeding-up-your-daily-business-process.html): Digital management of data and documents, speeding up your daily business process (17 words)
- [Webinar: Gain Clarity, Avoid Confusion -  Effortless Control of Master Data in EXTEDOpulse](/content/events-portal/webinar-gain-clarity-avoid-confusion-effortless-control-of-master-data-in-extedopulse.html): Webinar: Gain Clarity, Avoid Confusion -  Effortless Control of Master Data in EXTEDOpulse (18 words)
- [support/customer-portal-infopage/optimize-submission-document-creation-and-maintenance-with-extedopulse.html](/content/support/customer-portal-infopage/optimize-submission-document-creation-and-maintenance-with-extedopulse.html): Webinar: Optimize Submission Document Creation and Maintenance with EXTEDOpulse (13 words)
- [eCTD v4 Masterclass Reloaded - Part II: Learnings & Discussion](/content/events-portal/ectd-v4-masterclass-reloaded-part-ii-learnings-discussion.html): Webinar: eCTD v4 Masterclass Reloaded - Part II: Learnings & Discussion (15 words)
- [Agency Masterclass eCTD v4 - Part IV: Document Dynamic - Using the New Superpower of eCTD v4.0 Documents](/content/events-portal/agency-masterclass-ectd-v4-part-iv-document-dynamic-using-the-new-superpower-of-ectd-v4-0-documents.html): Webinar: Agency Masterclass eCTD v4 - Part IV: Document Dynamic - Using the New Superpower of eCTD v4.0 Documents (292 words)
- [support/customer-portal-infopage/raps-euro-convergence/index.html](/content/support/customer-portal-infopage/raps-euro-convergence/index.html): RAPS 2023 Euro Convergence (8 words)
- [eCTD v4.0 Masterclass VI - Scan the Next Era: Navigating Tomorrow's eCTD Submissions](/content/events/ectd-v4-0-masterclass-vi-scan-the-next-era-navigating-tomorrows-ectd-submissions.html): Webinar: eCTD v4.0 Masterclass VI - Scan the Next Era: Navigating Tomorrow's eCTD Submissions (18 words)
- [support/customer-portal-infopage/webinar-the-ema-ectd-v4-pilot-explained-key-concepts-industry-readiness-and-forward-compatibility.html](/content/support/customer-portal-infopage/webinar-the-ema-ectd-v4-pilot-explained-key-concepts-industry-readiness-and-forward-compatibility.html): Webinar: The EMA eCTD v4  Pilot Explained: Key Concepts, Industry Readiness and Forward Compatibility (198 words)
- [TOPRA Symposium 2026](/content/events/topra-symposium-2026/index.html): Event: TOPRA Symposium 2026 (146 words)
- [EMA Extends PMS Deadlines and Launches New PMS Functionalities for MAHs | EXTEDO](/content/blog/ema-extends-pms-deadlines-and-launches-new-pms-functionalities-for-mahs.html): The European Medicines Agency (EMA) has officially extended several PMS data submission deadlines and introduces new PMS functionalities in September 2025. (528 words)
- [Webinar: Unlock the Benefits of EXTEDO Training Programs](/content/events-portal/webinar-unlock-the-benefits-of-extedo-training-programs.html): Webinar: Unlock the Benefits of EXTEDO Training Programs (13 words)
- [support/customer-portal-infopage/raps-webinar-rim-the-data-foundation-your-compliance-strategy-depends-on.html](/content/support/customer-portal-infopage/raps-webinar-rim-the-data-foundation-your-compliance-strategy-depends-on.html): RAPS Webinar with InnovX: RIM - The data foundation your compliance strategy depends on (314 words)
- [support/customer-portal-infopage/gcc-regulatory-affairs-pharma-summit-2025/index.html](/content/support/customer-portal-infopage/gcc-regulatory-affairs-pharma-summit-2025/index.html): GCC Regulatory Affairs Pharma Summit 2025 (11 words)
- [MTH Test](/content/events/complimentary-webinar-mth-test/index.html): MTH Test (33 words)
- [Comparison between EU and US sequences and how to manage them in eCTD](/content/events-portal/complimentary-webinar-comparison-between-eu-and-us-sequences-and-how-to-manage-them-in-ectd.html): Comparison between EU and US sequences and how to manage them in eCTD (124 words)
- [EXTEDO Expands its Global Reach in South America | EXTEDO](/content/blog/extedo-expands-its-global-reach-in-south-america/index.html): EXTEDO Expands its Global Reach in South America (430 words)
- [EMA Officially Endorses the New EudraVigilance System for Adverse Reactions | EXTEDO](/content/blog/ema-officially-endorses-the-new-eudravigilance-system-for-adverse-reactions.html): The EMA management board endorsed the start of the official countdown for the launch of the EudraVigilance database system. (548 words)
- [support/customer-portal-infopage/agency-masterclass-ectd-v4-part-vi-scan-the-next-era-navigating-tomorrows-ectd-submissions.html](/content/support/customer-portal-infopage/agency-masterclass-ectd-v4-part-vi-scan-the-next-era-navigating-tomorrows-ectd-submissions.html): Webinar: Agency Masterclass eCTD v4 - Part VI: Scan the Next Era - Navigating Tomorrow's eCTD Submissions (250 words)
- [Webinar: Asia eCTD Highlights: Spotlight on China's eCTD v4 & Regional v1.1 for China and Singapore](/content/events-portal/webinar-asia-ectd-highlights-spotlight-on-chinas-ectd-v4-regional-v1-1-for-china-and-singapore.html): Webinar: Asia eCTD Highlights: Spotlight on China's eCTD v4 & Regional v1.1 for China and Singapore (240 words)
- [The Ukrainian eCTD in a Nutshell](/content/events/the-ukrainian-ectd-in-a-nutshell/index.html): Webinar: The Ukrainian eCTD in a Nutshell (11 words)
- [中国药品监督管理局（CDA）开始要求使用eCTD标准 | EXTEDO](/content/blog/e4-b8-ad-e5-9b-bd-e8-8d-af-e5-93-81-e7-9b-91-e7-9d-a3-e7-ae-a1-e7-90-86-e5-b1-80cda-e5-bc-80-e5-a7-8b-e8-a6-81-e6-b1-82-e4-bd-bf-e7-94-a8ectd-e6-a0-87-e5-87-86.html): 由于eCTD在亚洲相对较新，因此转型过程伴随着一系列独特的挑战。行业和监管当局可能对eCTD知之甚少，而且该地区很少有人有使用该标准的实际经验。为了确保符合eCTD，除了选择、配置和培训合适的eCTD发布软件员工之外，各组织机构还需要重组许多现有的业务和监管流程。  (18 words)
- [support/customer-portal-infopage/dia-2023-global-annual-meeting/index.html](/content/support/customer-portal-infopage/dia-2023-global-annual-meeting/index.html): DIA 2023 Global Annual Meeting (10 words)
- [Implementing M1 for eCTD submissions submitted to the WHO Prequalification Unit (PQT)](/content/events/complimentary-webinar-implementing-m1-for-ectd-submissions-submitted-to-the-who-prequalification-unit-pqt.html): Implementing M1 for eCTD submissions submitted to the WHO Prequalification Unit (PQT) (17 words)
- [support/customer-portal-infopage/end-to-end-management-of-regulatory-processes-and-digital-trust-in-the-drug-lifecycle.html](/content/support/customer-portal-infopage/end-to-end-management-of-regulatory-processes-and-digital-trust-in-the-drug-lifecycle.html): Webinar: End-to-End Management of Regulatory Processes and Digital Trust in the Drug Lifecycle (17 words)
- [support/customer-portal-infopage/webinar-pharmacovigilance-submissions-simplified-e2br3-faers-safety-reporting-explained.html](/content/support/customer-portal-infopage/webinar-pharmacovigilance-submissions-simplified-e2br3-faers-safety-reporting-explained.html): Webinar: Pharmacovigilance Submissions Simplified: E2B(R3), FAERS & Safety Reporting Explained (242 words)
- [What are the benefits of eCTD 4.0? | EXTEDO](/content/blog/what-are-the-benefits-of-ectd-4-0.html): eCTD 4.0 - the next major version of the electronic Common Technical Document brings a lot of benefits. We have compiled them for you.  (376 words)
- [Agency Masterclass eCTD v4 - Part IV: Document Dynamic - Using the New Superpower of eCTD v4.0 Documents](/content/events/agency-masterclass-ectd-v4-part-iv-document-dynamic-using-the-new-superpower-of-ectd-v4-0-documents.html): Webinar: Agency Masterclass eCTD v4 - Part IV: Document Dynamic - Using the New Superpower of eCTD v4.0 Documents (291 words)
- [Webinar: Audit Readiness in the Digital Age of Life Sciences - Part I](/content/events/webinar-audit-readiness-in-the-digital-age-of-life-sciences-part-i.html): Webinar: Audit Readiness in the Digital Age of Life Sciences - Part I (18 words)
- [RAPS Convergence Montreal](/content/events/raps-convergence-montreal/index.html): RAPS Convergence 2023 (8 words)
- [support/customer-portal-infopage/webinar-quality-unlocked-how-to-create-a-qms-masterpiece.html](/content/support/customer-portal-infopage/webinar-quality-unlocked-how-to-create-a-qms-masterpiece.html): Webinar: Quality Unlocked: How to create a QMS masterpiece (14 words)
- [World Patient Safety Congress Americas 2026](/content/events-portal/world-patient-safety-congress-americas-2026/index.html): Event: World Patient Safety Congress Americas 2026 (128 words)
- [Webinar: Spot the Differences: Practical Nuances in EMA vs. US FDA eCTD v4](/content/events/webinar-spot-the-differences-practical-nuances-in-ema-vs-us-fda-ectd-v4.html): Webinar: Spot the Differences: Practical Nuances in EMA vs. US FDA eCTD v4 (232 words)
- [support/customer-portal-infopage/webinar-ai-in-safety-management-boost-your-efficiency.html](/content/support/customer-portal-infopage/webinar-ai-in-safety-management-boost-your-efficiency.html): Webinar: AI in Safety Management - Boost Your Efficiency! (14 words)
- [Webinar: The Tiny but Mighty Differences of DMF Submissions: US FDA vs Health Canada](/content/events-portal/webinar-the-tiny-but-mighty-differences-of-dmf-submissions-us-fda-vs-health-canada.html): Webinar: The Tiny but Mighty Differences of DMF Submissions: US FDA vs Health Canada (19 words)
- [support/customer-portal-infopage/ready-set-go-a-practical-guide-to-empower-your-organization-with-a-quality-management-system.html](/content/support/customer-portal-infopage/ready-set-go-a-practical-guide-to-empower-your-organization-with-a-quality-management-system.html): Ready, set, go! A practical guide to empower your organization with a Quality Management System (20 words)
- [support/customer-portal-infopage/ectd-v4-masterclass-reloaded-part-ii-learnings-discussion.html](/content/support/customer-portal-infopage/ectd-v4-masterclass-reloaded-part-ii-learnings-discussion.html): Webinar: eCTD v4 Masterclass Reloaded - Part II: Learnings & Discussion (15 words)
- [support/customer-portal-infopage/the-wins-of-harmonizing-european-drug-safety-processes.html](/content/support/customer-portal-infopage/the-wins-of-harmonizing-european-drug-safety-processes.html): The Wins of harmonizing European Drug Safety Processes (13 words)
- [Pharmacovigilance World 2026 (clone)](/content/events-portal/pharmacovigilance-world-2026-0/index.html): Event: Pharmacovigilance World 2026: Meet the EXTEDO team (148 words)
- [Grand African Virtual Pharma B2B (EARAPA)](/content/events/grand-african-virtual-pharma-b2b-earapa/index.html): Event: Grand African Virtual Pharma B2B (EARAPA) (69 words)
- [Unleash Your Full Potential: The New Superhero on the Horizon - eCTD 4.0](/content/events/complimentary-webinar-the-new-superhero-on-the-horizon-ectd-4.html): Unleash Your Full Potential: The New Superhero on the Horizon - eCTD 4.0 (18 words)
- [medicines for europe - Regulatory Affairs Conference 2026](/content/events-portal/medicines-for-europe-2026/index.html): Event: EXTEDO at medicines for europe - Regulatory Affairs Conference 2026 (243 words)
- [DIA 2023 Global Annual Meeting](/content/events/dia-2023-global-annual-meeting/index.html): DIA 2023 Global Annual Meeting (10 words)
- [eCTD v4.0 Masterclass II - Architecture of Change: The Structure of eCTD v4.0](/content/events-portal/ectd-v4-0-masterclass-ii-architecture-of-change-the-structure-of-ectd-v4-0.html): eCTD v4.0 Masterclass II - Architecture of Change: The Structure of eCTD v4.0 (18 words)
- [eCTD 4.0 - No Need to Fear](/content/events-portal/ectd-40-no-need-to-fear/index.html): eCTD 4.0 - No Need to Fear (12 words)
- [support/customer-portal-infopage/webinar-dmf-and-api-mf-compliance-in-the-southern-hemisphere-a-focus-on-australia-and-south-africa.html](/content/support/customer-portal-infopage/webinar-dmf-and-api-mf-compliance-in-the-southern-hemisphere-a-focus-on-australia-and-south-africa.html): Webinar: DMF and API MF Compliance in the Southern Hemisphere: A Focus on Australia and South Africa (22 words)
- [Webinar: Master ASMF/CEP for Western Europe - Seems quite similar but don’t fall for it!](/content/events/webinar-master-asmfcep-for-western-europe-seems-quite-similar-but-dont-fall-for-it.html): Webinar: Master ASMF/CEP for Western Europe - Seems quite similar but don’t fall for it! (20 words)
- [support/customer-portal-infopage/the-ukrainian-ectd-in-a-nutshell/index.html](/content/support/customer-portal-infopage/the-ukrainian-ectd-in-a-nutshell/index.html): Webinar: The Ukrainian eCTD in a Nutshell (11 words)
- [eRA Conference 2023](/content/events-portal/era2023/index.html): eRA 2023 Conference (8 words)
- [GCC Regulatory Affairs Pharma Summit](/content/events/gcc-regulatory-affairs-pharma-summit/index.html): GCC Regulatory Affairs Pharma Summit (10 words)
- [support/customer-portal-infopage/gcc-regulatory-affairs-pharma-summit-2024/index.html](/content/support/customer-portal-infopage/gcc-regulatory-affairs-pharma-summit-2024/index.html): GCC Pharma Summit: Meet the EXTEDO team! (11 words)

## About Pages

- [company/about/index.html](/content/company/about/index.html): EXTEDO was founded with a simple vision: to help life sciences organizations ensure Effortless Compliance with industry standards & regulatory requirements (1,402 words)

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