November 4, 2021

How To Tell A Compelling CMC Story In Your NDA/BLA Application

Storytelling is integral to the pharmaceutical regulatory process. It’s really what your new drug application (NDA) or biologics license application (BLA) is all about. It’s about deciphering the data to tell a reviewer how your process and product works.
August 3, 2022

Understanding the Relationship Between CMC & GMP

CMC information reinforces the connection between the quality of a candidate drug used in clinical studies and the end product marketed to consumers. It effectively outlines critical quality attributes across the full life cycle of drug products, from clinical development to commercial scale production. Like current good manufacturing practices (cGMP, or GMP), CMC reviews have regulatory requirements established by the US FDA. But where the goals of these two pharmaceutical control strategies are closely aligned, they differ significantly in approach and regulation.
January 6, 2023

Your Company’s FDA Meeting Survival Guide

Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
January 7, 2023

Chemistry, Manufacturing and Controls (CMC) for Cell & Gene Therapy (CGT) Products

Cell and gene therapies for treating multiple myeloma, such as CAR-T, have resulted in breakthrough health outcomes for patients. In the last decade, approval of cell and gene therapy (CGT) products has increased significantly. Multiple other products are in clinical development for solid tumors, genetic deficiencies, and infections that promise more effective […]