Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC
Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the…
Certara2025年2月19日
Streamline Clinical Data Publication Under EMA Policy 0070
2025年2月14日 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…
Certara2025年2月14日
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline
We look at the growing regulatory trend of rolling NDA and BLA submissions to help…
Certara2025年2月3日
How to Validate Your Clinical Data Using FDA Validation Rules
2025年1月30日 For clinical data managers, understanding clinical data validation and applying FDA validation…
Certara2025年1月30日
Anonymization vs. Redaction of Clinical Trial Data
2025年1月17日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…
Certara2025年1月17日
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know
2024年12月3日 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…
Certara2024年12月3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
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
