Drug regulatory affairs


Regulatory Plus offers the following services:


Development of new drug products:

  • Preparation regulatory strategy
  • Planning of meetings with the authorities, preparation of documentation and participation in meetings
  • Preparation of application for Orphan Designation in the EU and USA
  • Preparation of clinical trial application in the EU and the USA
  • Preparation of investigators brochure
  • Preparation of application for marketing authorisation
  • Preparation of response document to the authorities

Established products:

  • Preparation of variation applications/amendments and response to the possible questions
  • Preparation of annual report
  • Preparation of drug master file