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
