Regulatory Service and Support

CPC offers comprehensive regulatory support, encompassing the preparation of all necessary documentation for drug substances. This includes creating briefing packages, compiling relevant sections for IND and NDA dossiers, as well as handling DMFs and CEPs.

By choosing to collaborate with CPC, you gain access to professional regulatory support and services. Our global presence and extensive expertise in obtaining and maintaining regulatory approvals for therapeutic peptide drug substances position us as a valuable partner. Our collaborative approach ensures that clients, regardless of the manufacturing site involved, can tap into the full regulatory knowledge and experience available within CPC.

The Regulatory Affairs team at CPC takes on the responsibility of addressing questions or requests from health authorities, working closely with our clients. We actively participate in meetings with clients and regulatory authorities to ensure successful regulatory approval. Additionally, our services extend to the maintenance of regulatory documentation and approvals throughout the product's life cycle.