Fundamentals of regulatory writing: the document development process Article Fundamentals of regulatory writing: the document development process Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across…Jim Gallagher2021 年 6 月 22 日
Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting Blog 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…Oxana Iliach, PhD2021 年 6 月 15 日
Certara Acquires UK-based Insight Medical Writing Press Release 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 On-Demand Webinar 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 Blog 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…Lisa Hove2021 年 5 月 14 日
Plan to Accelerate Your Time to Drug Submissions On-Demand Webinar 加速药物申报全流程计划 There are common themes driving how quickly you can get from your last database lock…Jim Gallagher2021 年 4 月 20 日