IMPORTANT KEY TO SUCCESS

Deployment of the correct strategy for filing in each region or country is vital for registration success.

In Europe the choice of the correct submission procedure (Orphan Drug, Centralised, Mutual Recognition, Decentralised Procedure) is a critical element in this. For the Mutual Recognition and Decentralised Procedures the choice of Reference Member State and Concerned Member States is key to avoiding delays in approval and marketing.

What we offer:

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