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. The quality portion of a submission (such as an...

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 December 5, 2024 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

The world of electronic regulatory submissions is about to change with the introduction of eCTD (Electronic Common Technical Document) v4.0. This latest version of the standard includes updated specifications and guidelines for the preparation and submission of electronic regulatory documents.