CMC Scientific Support

Chemistry, Manufacturing, and Controls (CMC) scientific support addresses the development and characterization of drug substances and drug products. CMC activities play a critical role in ensuring product quality, consistency, and regulatory compliance.

CMC scientific work spans development through commercialization, requiring coordination between formulation, manufacturing, and quality functions. Early scientific planning supports scalable processes and reduces downstream regulatory risk.

Strong CMC strategies support efficient development and successful regulatory submissions.

CMC scientific support commonly includes:

• CMC strategy development

• Product characterization and comparability support

• Process understanding and optimization

• Alignment with regulatory expectations

• Scientific documentation related to CMC activities