FAQs on Developing EMA Policy 0070 Submissions
In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…
CertaraNovember 1, 2024
How To Respond to Health Authority Questions
Your biotech company has just submitted the marketing application for your first drug product. It’s…
CertaraOctober 25, 2024
Why You Need an Integrated Development Plan
Learn about the Integrated Development Plan for successful drug development & its relation to the…
CertaraOctober 17, 2024
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…
CertaraSeptember 23, 2024
Resmetirom: A pioneering NASH clinical program
Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…
CertaraAugust 23, 2024
Subject Exposure in Aggregate Safety Reports & Common Issues
All new and existing drugs should be safe, effective, and efficacious for the treated populations.…
CertaraAugust 16, 2024
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…
CertaraJuly 26, 2024
What is a Scientific & Medical Publications Professional?
Would your drug development program benefit from partnering with experts in scientific and medical communications…
CertaraJuly 19, 2024
Generative AI Tools for Regulatory Writing
Regulatory writing is a crucial component of the drug development process. Regulatory writers must understand…
CertaraJune 20, 2024
