Chemistry, Manufacturing and Controls (CMC)
That part of pharmaceutical research and development that focuses on the nature of the active ingredient and its formulation, the way they’re manufactured, and the way the production processes are controlled. The Chemistry, Manufacture, and Control section of an Investigational New Device Exemption application includes the description of the active ingredients, their formulations, and the production processes used to manufacture them.
More information about Chemistry, Manufacturing and Controls (CMC)
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