Medicinal products
- Coordination and conducting of registration procedures.
- Conducting of post-registration variations, changes of the Marketing Authorization Holder and renewal procedure (taking into account national requirements for MRP / DCP procedures).
- Keeping records of registration and post-registration documents (dossier)
- Graph form notification
- Verification of the graph forms texts
- Conformity assessment of packaging materials for centralized procedures
- Preparation and translation of the packaging materials according to Polish Regulatory Authorities (URPLWMiPB - Registration Office for Medicinal Products) requirements
- PIL readability testing preparation according to EU requirements. (with final report).
- Organizing of sworn translations required for procedures of Registration Office for Medicinal Products and Ministry of Health
- Daily contact with the Registration Office for Medicinal Products (Regulatory Authorities)