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Is Ignorance of Regulations Delaying Your New Product Launch?

By: Alex D. Kanarek, Ph.D. and Patricia Seymour
Reprinted with permission of Life Science Leader, January 2010

Sometimes drug development can feel like a Sisyphean challenge in the progress from laboratory bench to the clinic and, for a small percentage of companies, to the market. Global regulatory requirements, embodied in regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), collectively referred to as GxP, can intensify this frustration. These requirements exist, however, for very valid reasons, and when followed properly can actually decrease the risk and frustration that frequently goes hand-in-hand with drug development by providing a clear compliance roadmap.