Strong regulatory
affairs department
to support our clients

Galenicum has a very strong Regulatory Affairs department with vast experience in national and European procedures. Since 2006, Galenicum has been authorised to register products across Europe.

The regulatory affairs capabilities of Galenicum include:

  • Preparation of new dossiers in NeeS and e-CTD format.
  • Preparation of new DMFs.
  • Audits of dossiers and DMFs.
  • Submission and follow-up on dossiers, both national and European.

Our Regulatory Affairs Department provides continuous support to our clients ensuring high-quality and timely registrations.

We are able to handle national, MRP and DCP procedures.
Countries with registered products