Helping Sponsor Meet EMA Policy 0070 Requirements
The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for…
Certara2025 年 1 月 7 日
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
How To Respond to Health Authority Questions
Your biotech company has just submitted the marketing application for your first drug product. It’s…
Certara2024 年 10 月 25 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
