Vetter Development Service –
Clinical drug development for your compound
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:
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.
The Marketing Authorization Application (MAA) is a common document used as the basis for a marketing application across all European markets, plus Australia, New Zealand, South Africa, and Israel. This application is based on a full review of all quality, safety, and efficacy data, including clinical study reports.
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into commerce in the U.S.
An Investigational New Drug application is provided to the FDA to obtain permission to test a new drug in humans in Phase I – III clinical studies. The IND is reviewed by the FDA to ensure that study participants will not be placed at unreasonable risk.
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new chemical pharmaceutical for sale and marketing in the U.S.
A New Drug Application (NDA) is the vehicle submitted to the FDA by drug companies in order to gain approval to market a new product. Safety and efficacy data, proposed package labeling, and the drug’s manufacturing methods are typically included in an NDA.