Free Guide: What you need to know about active substance registration strategy?

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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.

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