Structured Product Labeling (SPL) Essentials for Regulatory Affairs

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?

Implementation expectations of eCTD 4.0

Key Concepts Behind eCTD 4.0 and their Impact on Product Submissions

The Drivers and Benefits behind eCTD 4.0

The EMA prepares itself for Brexit

The Chinese Food & Drug Administration moves to eCTD