The preparation of approval dossiers and the supervision of approvals can now only be carried out by specialists. For the area of "regulatory affairs" we offer the following services, which can be called up on a project-related basis:

  • Execution of approval procedures (national and EU-wide) from the preparation of the necessary documents to the granting of approval
  • Updating and transformation of registration documentation into "CTD format"
  • Submission of applications for marketing authorization renewal including preparation of the "Clinical Addendum Overview
  • Preparation, processing, submission (including compliance with the AMG Submission Regulation and the so-called Variation Regulation) and deadline monitoring of notifications of variations.

We carry out regulatory tasks in cooperation with a network of specialists who are particularly familiar with the respective local and national conditions.