Liaison with the regulatory authorities

Your direct line to success

The national authorisation phase begins immediately after the completion of the European MRP or DCP. This means that all the product information texts have to be made available in the respective national languages within a very few days.

Instead of mere “translation”, this entails the careful transfer of the English submission texts to other languages, taking into account the relevant format specifications and linguistic nuances. We have many years of experience with the rapid and reliable production of such text material.

On the basis of our ongoing contacts with the regulatory authorities we guarantee smooth progress – up to and including the issue of the marketing authorisation certificate in all the countries of the European Economic Area (EEA) plus Switzerland.

Based on the multilinguality of our team members and their familiarity with the local requirements in non-EU countries we are in trustful contact also with authorities outside Europe.