• Unifarm, Viale Andrea Doria 21, 95125 Catania
  • +39 095 7167514
  • +39 095 2865220
  • info@unifarm.org

Regulatory affairs services:

- revision and assesment of technical and scientific data;
- bibliographic research;
- preparation and management of the Site Master File;
- consulting on interpretation of regulatory requirements and guidance;
- strategic regulatory planning;
- preparation and assembly of submissions for the ethical examination and obtaining approval for clinical trial from the ethic committees.