The Role of Regulatory CMC in Pharmaceutical Development

Burbank, California, resident and independent regulatory consultant Robert Gadimian has extensive experience in the drug approval process. As part of his work, Robert Gadimian has familiarity with regulations related to Chemistry, Manufacturing, and Controls (CMC).

The role of regulatory CMC has become so important that the field is expanding to become its own sector. Called CMC Regulatory Affairs (RA), the field is an important part of drug and product development along the entire cycle of development, licensing, manufacture, and marketing. CMC RA is a governance process that guarantees drug development and manufacturing adhere to regulatory guidelines established by governing agencies such as the Food and Drug Administration.

The activities involved with CMC RA are twofold: manufacturing and quality control testing of the product. Other activities that occur include defining specifications and stability of the product, defining the place where the product is manufactured, and specifying the tools used to support the location where products are manufactured (i.e., facility design, operation, maintenance, and qualification).

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