CMC Writing Support Helps Client Lift Clinical Hold Blog Post

In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the quality and consistency of pharmaceutical products. 申报材料(如 IND、NDA、BLA、MAA 等)的质量部分因药物物质/活性药物成分 (API...

Sneak Preview: Introducing TFL Studio Blog Post

Get your preview of the upcoming Tables, Figures, and Listings (TFL) Module in Phoenix Cloud. Learn how this innovative tool will revolutionize the way you create and manage TFLs, providing faster results, enhanced flexibility, and streamlined collaboration.

Key development considerations for cell therapies Blog Post

Rajesh Krishna, PhD Kathryn Brown 2024 年 12 月 5 日 What is a “cell therapy”? Nearly every recent oncology clinical conference has featured this phrase. Cell therapies, such as CAR-Ts (chimeric antigen...

GlobalSubmit 4.0 Webinars Blog Post

电子通用技术文档(eCTD)v4.0 标准的发布将彻底改变全球电子监管申报领域。该最新版本包含更新的规范与指南,涵盖电子法规文档准备与提交全流程。