Dossier management

Efficient compilation of EU dossiers

Benefit from our extensive know-how in the creation of marketing authorisation dossiers and documentation for product maintenance activities (lifecycle management) – either step by step or as a complete service package. We have the necessary experience for completing the various CTD modules (human) and other electronic formats (e.g. veterinary). What’s more, we are completely familiar with all the relevant EU laws and guidelines.