Drug substance quality must be demonstrated in the marketing authorisation application, and in Europe, there are three different ways to do this. The choice depends mainly on the API in question.
The easiest way is to go with CEP whenever possible. In Europe, the CEP procedure offers a simple way for applicants to submit API information to the authorities. Compared to ASMF or including the full details in the marketing authorisation application, CEP has many advantages.
We have created a guide on the basic information you need to know about registration, so that you can make the best choices for your project.
Global pharma company & Medfiles: Cooperation in obtaining and maintaining marketing authorisations in the EU
“Medfiles has been a valuable partner for us during the registration and maintenance of products in Europe. They consistently provide prompt and accurate responses whenever there are inquiries or concerns related to European approvals.”
This is how a client from outside the EU, who has been working with Medfiles for 7 years, describes the partnership. The company initiated cooperation with Medfiles when they required assistance in entering the European market. The cooperation has involved applying for new marketing authorisations as well as managing products post-approval.
