Structured Product Labeling (SPL) Essentials for Regulatory Affairs

EMA Updates Technical Guidance for eCTD Submissions in the EU

MHRA updates Guidance for Centrally Authorized Products (CAPs) to UK Marketing Authorization (MAs)

New EU Guidance on Data Submission for Investigational Medicines

Australia readies itself for eCTD only

China NMPA will be accepting eCTD submissions from 29th December 2021

Gens & Associates IDMP Vendor Assessment & Capability Survey - How does MPDmanager powered by CARA compare to competing products?

The FDA’s OPDP eCTD is now in effect - what does it mean for you?

OMS to become mandatory for all submissions to EMA

The Mystery of the EU IG - Insider Perspective

EXTEDO extends its EXTEDOpulse RIM software solution using Generis’s CARA™ foundational content & business process management platform

EXTEDO Donates Laptops to Disadvantaged Children for Homeschooling

Implementation of the new Veterinary Medicines Regulation