Regulatory Affairs

Regulatory Affairs consultancy

Assistance can be offered with respect to:

  • Audits of registration files for drugs and technical files for medical devices
  • Feasibility of the file in the respective country in Europe
  • Advice on how to update the file
  • Preparation of the registration file
  • Preparation of variations and Periodic Safety Update Reports
  • Design of Module 2 documents of the Common Technical Document
  • Contact with European Competent Authoritities and Notified Bodies
  • Certification of medical devices according to new EU Directives