Strategy and Procedures

To achieve registration success, deployment of the correct strategy for filing in each region/country is crucial. In Europe, the choice of the correct submission procedure (such as orphan drug, centralised, mutual recognition or decentralised procedure) is a critical element.

To avoid delays in approval and marketing, the choice of reference member state and concerned member states for the mutual recognition and decentralised procedures is key.

3R PHARMA CONSULTING offers:

• Consultation on national or European scientific advice
• Assistance arranging scientific advice meetings with national agencies
• Consultation on an appropriate regulatory strategy for filings
• Review and assessment of regulatory documents