March 7, 2019

FDA Unveils Plan for Draft CMC Guidance in 2019

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue new draft and revised draft quality/chemistry manufacturing and controls (CMC) guidance documents spanning different categories, from biosimilars to microbiology to Pharmaceutical Quality, in 2019.
May 30, 2019

Need to Know about CMC Regulatory Affairs? Consider What Makes a Great Philly Cheesesteak!

what makes a drug development program? Much like a Philly cheesesteak, the pursuit of greatness is the assurance that any given compound meets requisite technical and quality elements in each stage of development to allow for the ultimate successful commercialization of the drug.
February 28, 2020

Why Your Program Needs a Biologics CMC Consultant

Looking for answers? Where are you at with your process and controls? Who is managing the operations? What bioassays are necessary for your product? When, where and how to validate your bioassay? 
October 20, 2022

Why You Should Consider a Biologics Consulting Service

Biologics are complex molecular entities that require extensive planning and development strategies to control development costs, ensure compliance with regulations, and speed up a product to commercialization. Hiring a biologics consultant ensures you receive expert advice and support throughout the entire CMC development process. In this article, we will outline why you should consider a biologics consulting service and what benefits this will have for your company.