Upcoming Changes in eCTD EU Module 1 Specification

eCTD Publishing Standards: What you need to be aware of when moving from paper/NeeS to eCTD

New EU General Data Protection Regulation (GDPR)

eCTD Related Guidelines for US FDA and EU

Submission Platforms in EU and Further Changes

EXTEDO Expands its Global Reach

PDF requirements for US FDA eCTD submissions

New: RImanager Starter Package available for quick and cost-effective implementation – Best-practice approach jointly developed by EXTEDO and Werum IT Solutions

Submission of eCTD submissions to US FDA using the electronic gateway

eSubmission Roadmap: The Decline of NeeS & the Roadmap to eCTD

EXTEDO Announces New Regional Partnership with Jiaxing Taimei Medical Technology Co., Ltd.

The European Medicines Agency (EMA) comes to Amsterdam

eCTD 4.0: What's new in the Granularity Update?