FAQs on Developing EMA Policy 0070 Submissions
In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…
Certara2024年11月1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
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
What is a Scientific & Medical Publications Professional?
Would your drug development program benefit from partnering with experts in scientific and medical communications…
Certara2024年7月19日
Generative AI Tools for Regulatory Writing
規制関連文書の作成は、医薬品開発プロセスの重要な要素です。Regulatory writers must understand…
Certara2024年6月20日
