Sophena - Your partner in regulatory affairs since 2010

As a service provider we take over all tasks connected to regulatory affairs for medicinal products.

Submission of new applications for DCPs, MRPs or national procedures in all EU-countries and Switzerland

  • Preparation of registration dossiers
  • Submission of the applications
  • Procedure management
  • National phase

Maintenance of existing marketing authorisations

  • Variations
  • Renewals
  • Digitalisation/conversion of dossiers
  • Preparation of eCTDs

We are gladly at your disposal to answer any questions that you may have concerning our offers and services. Simply contact us by phone (+49 8221 9160331) or by email (