Regulatory Service and Support
The regulatory support provided by the PolyPeptide Group includes the preparation of all regulatory documentation in relation to the drug substance such as briefing packages, applicable sections for IND/IMPD and NDA/MAA dossier, as well as DMFs/ASMFs and CEPs.
Regulatory Affairs at PolyPeptide Group will take the responsibility for responses to questions or requests from the health authorities in close collaboration with our client. We will participate in meetings with clients and regulatory authorities in order to secure regulatory approval. Our services also includes maintenance of regulatory documentation and approvals throughout the product life cycle management.
By choosing to work with Polypeptide Group, you have access to professional regulatory support and services including the vast experience and expertise PolyPeptide has globally with obtaining and maintaining regulatory approvals for therapeutic peptide drug substances.
Each manufacturing site within PolyPeptide has Regulatory Affairs experts. Within the Group, Regulatory Affairs works closely together meaning that our clients, independent of the manufacturing site, have access to the full regulatory expertise within PolyPeptide including several senior experts.
For more information, please see Commercial Phase – Development and Clinical Phase – Local Regulatory Knowledge and Experience