Chemistry, Manufacturing, and Controls (CMC)

Expert guidance. Regulatory insight.

inVentiv Health Clinical regulatory and pharmaceutical experts can guide you on CMC (Chemistry, Manufacturing, and Controls) regulatory and technical strategy for development of both chemical drug and biotechnological/biological products from pre-IND through phase I/II/III and marketing approval. Through our experience and practical knowledge of the drug development process and the experts of former reviewers of US regulatory agency, inVentiv Health Clinical provides strategic regulatory insights and important recommendations on development of CMC information and data to meet current global regulatory requirements. inVentiv Health Clinical can help you:

  • Perform gap analysis on CMC development program to identify deficiencies and provide recommendations 
  • Provide advice on CMC regulatory strategy for different phases of drug development
  • Develop characterization, release and stability programs for product candidates of both small molecules and biological products.
  • Prepare CMC regulatory submissions including pre-IND meeting, INDs/CTAs, NDAS/BLAs/MAAs, and DMFs.Assist in interactions with regulatory agencies on issues related to CMC Consult on GMP issues and vendor audits