GMP Compliance and Regulatory Support
At the PolyPeptide Group, peptide active pharmaceutical ingredients (APIs) are manufactured in compliance with ICH guidelines including Q7 and other related and applicable sections. Manufacturing is performed in facilities which have been inspected by the US FDA and several other regulatory authorities either for routine site inspections or for approval of specific products.
Our regulatory support includes assistance in the preparation of all documents required by the regulatory authorities. This includes generation of a pre-IND meeting dossier or package, a CMC section for an IND filing, assistance with responses to questions by the reviewing agencies, visiting the regulatory authorities at the request of the client if necessary, and NDA filing.
Other services including stability studies, generation of reference standards, analytical method validation for Phase II or Phase III products, or Process Validation activities in anticipation of commercial production, will be tailored to the requirement of your product life cycle stage.