Streamlining the Preparation of 1-Year and 2-Year PSURs
We explore how we helped one client deliver a last-minute addition to a Periodic Safety…
Certara2024年12月18日
Delivering High-Quality, Timely Responses to EMA Safety Queries
A pharmaceutical company approached us for support with eight safety-related queries from the European Medicines…
Certara2024年12月12日
CMC Writing Support Helps Client Lift Clinical Hold
In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the…
Certara2024年12月10日
A medical writer’s guide to collaborative authoring
Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…
Certara2024年11月22日
Why you need an integrated development plan
Learn about the Integrated Development Plan for successful drug development & its relation to the…
Certara2024年10月17日
Why cancer drug programs need human mass balance studies
Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies…
Certara2024年9月23日
Resmetirom: A pioneering NASH clinical program
Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…
Certara2024年8月23日
Subject exposure in aggregate safety reports & common issues
All new and existing drugs should be safe, effective, and efficacious for the treated populations.…
Certara2024年8月16日
How does a clinical development plan help drug programs?
How important is a clinical development plan? Your biotechnology start-up’s candidate asset has an intriguing…
Certara2024年7月26日
