Documentation and submission support
Vetter regulatory Chemistry, Manufacturing, Control (CMC) experts are well versed in the required information, submission formats, and approval processes of various authorities around the globe. We’ll work with you to guide and streamline your preparation of the CTD documentation necessary for clinical submission and market authorizations. We will support you by writing and reviewing the dossier sections of Module 3 relevant to the Vetter process and by responding to deficiency letters for:
- Investigational New Drug (IND) Applications
- Investigational Medicinal Drug Dossier (IMPD)
- New Drug Application (NDA)
- Biologic License Application (BLA)
- Marketing Authorization Application (MAA)
Vetter undergoes routine regulatory inspections with authorities from around the globe, with our facilities meeting the stringent requirements of the European, US, and Japanese markets. This includes routine GMP and pre-approval inspections, either on-site or paper-based.