Regulatory Service and Support – Commercial Phase

Compilation of the drug substance CTD sections of Module 1, 2 and 3 for a NDA/MAA submission
The CTD sections can be prepared either in PolyPeptide’s template or in any client template
Compilation and submission of DMF/ASMF in any market
Compilation and submission for CEP (COS) certificate
DMF/ASMF/CEP on file at regulatory authorities for many generic drug substances
Access to open part DMF for client’s submission in less regulated markets
Professional support in responding to review questions from regulatory authorities
Life cycle maintenance of all regulatory dossiers, independent on the submission route
Preparation and submission of variations and changes
Advice and strategies for obtaining regulatory approval
Close and transparent collaboration with clients