Formulating Safety and Quality - Comprehensive CMC Testing Solutions


The chemistry, manufacturing, and control (CMC) testing of drug substances and products performs a critical function in guaranteeing the quality of pharmaceuticals entering clinical trials. These validated methods and technologies can also play a vital role in commercial manufacturing, as one component of a complete quality control regimen.

With CMC testing, pharma manufacturers document acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug substance and drug product, including enough information to support stability.