Administrative documents

A valid Module 1/Part 1– a challenge to your marketing authorisation department

The validation of your marketing authorisation application depends on the compilation of a complete Module 1 (human) and Part 1 (veterinary medicinal products), respectively. Alongside the supra-regional EU regulations, you also have to comply with national requirements, which vary from country to country. It is essential to have up-to-date knowledge of the necessary documents. Thanks to our continuous contacts with the regulatory authorities, we are ideally equipped to guide your application through the validation process. Electronic document formats are an integral part of our consulting portfolio.