Approval Documentation

As early as the clinical phases, we help our customers prepare the documents required for international approvals. Members of the Vetter staff who have extensive knowledge not only of the Vetter systems but also of FDA and the EMEA requirements, carry out the so-called technical writing. For the preparation of the dossier parts requiring approval (EU/US-CTD Module 3, Drug Product Section), we can react flexibly to customer requirements. As a result of the many years of our staffs experience and high level of expertise, we are able to help that the approval process is handled both efficiently and economically.