Pharmaceutical registration is one of the most difficult procedures which takes long time and requests closed follow-up from the beginning. We provide the full service to support this registration from the initial advisory for preparation of application documents, including the professional gap analysis, if requested. We also provide the advisory service in case you just need the information of related regulations.

Pharmaceutical Regulatory Affairs Services:

  • Submission Dossier Preparation
  • Gap analysis and Consulting
  • Label Preparation & Review
  • Translations & Updated of Product information
  • Marketing Authorisation Applications
  • Regulatory Agency Interactions
  • Local RA activities (annual reports, cross-functional tasks)