CMC stands for Chemistry, Manufacturing, and Controls. It is a critical aspect of pharmaceutical development and regulatory applications that ensure the quality, safety, and consistency of drug products throughout their lifecycle. CMC encompasses a comprehensive set of activities and data related to the chemical composition, manufacturing processes, specifications, and control measures for both the drug substance and the final drug product.
CMC is a critical aspect of drug development as it establishes the foundation for product quality and consistency. It is essential for regulatory submissions, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA). Compliance with CMC requirements is crucial for obtaining regulatory approval for the drug product.
Throughout the drug development cycle, CMC plays a central role in maintaining product consistency, supporting clinical trials with the same formulation used in commercial production, and ensuring patient safety. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), closely evaluate the CMC data as part of their assessment of a drug product’s safety and efficacy.
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