Regulatory requirements for peptide drug substances are unique and continually evolving. The PolyPeptide Group has the experience and the knowledge to assist and advise its customers through every step and change in the regulatory approval cycle.
PolyPeptide Group’s regulatory support includes preparation of all documents related to the drug substance required by the regulatory authorities. Regulatory support also includes assistance in meetings with regulatory agencies and, preparation of responses to questions from regulatory authorities in connection with the review of regulatory submissions.
The following Regulatory Agencies have inspected the PolyPeptide Group’s facilities globally: