Complex patient profile and narrative template needs
A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative…
CertaraJune 24, 2021
Fundamentals of regulatory writing: the document development process
Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across…
CertaraJune 22, 2021
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…
CertaraJune 15, 2021
Certara Acquires UK-based Insight Medical Writing
Expands global reach and deepens regulatory expertise PRINCETON, NJ.— June 10, 2021– Certara, Inc., the…
CertaraJune 10, 2021
Using Authoring Templates to Write the Right Way
Creating submission-ready regulatory documents that are consistent in presentation, appropriate in content, and formatted to…
CertaraMay 25, 2021
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…
CertaraMay 14, 2021
