Chemistry, Manufacturing, and Controls (CMC)

Expert guidance. Regulatory insight.

PharmaNet/i3 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, PharmaNet/i3 provides strategic regulatory insights and important recommendations on development of CMC information and data to meet current global regulatory requirements. PharmaNet/i3 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