Submission to Health Authority & Approval

  • Dossier submission - Electronic / Paper technical data preparation with local forms/application and actual submission to respective Health Authority.
  • Labeling Management - Preparation of draft Labels for Primary and Secondary Packaging Materials, Patient Information Leaflet & SmPC. Side by Side comparison of Labels in reference to innovator
  • Local Translation - We support translation of dossier as well as labeling content in multiple languages
  • Agency Meetings if any - Arranging meeting schedule with Health Authority for technical discussion.
  • Query response - Preparation of query response based on Health Authority‚Äôs query and timely submission to our client / authority