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’s query and timely submission to our client / authority