Complex patient profile and narrative template needs
A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative…
Jim Gallagher2021年6月24日
Fundamentals of regulatory writing: the document development process
Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across…
Certara2021年6月22日
Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting
Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory…
Certara2021年6月15日
Certara Acquires UK-based Insight Medical Writing
Expands global reach and deepens regulatory expertise PRINCETON, NJ.— 2021年6月10日– Certara, Inc., the…
Jieun Choe2021年6月10日
Using Authoring Templates to Write the Right Way
Creating submission-ready regulatory documents that are consistent in presentation, appropriate in content, and formatted to…
Jim Gallagher2021年5月25日
Why Your Regulatory Writers Need eCTD Authoring Templates
If you’ve heard about eCTD authoring template suites before, but you’re not sure what they…
Certara2021年5月14日
