KBM Pharma

Regulatory Affairs

We tailor our services to meet your specific needs.

It is not just about submitting of applications.
We will liaise with various authorities on your behalf, and act as the official EU contact for your procedure.

Our fields of competence:

  • Translation of product information, evaluation of relevant documentation, advice on labelling and marketing materials;
  • Regulatory maintenance;
  • Pharmacovigilance;
  • Reimbursement;
  • Comprehensive information on local legislation and requirements.

We tailor our services to meet your specific needs and budget.