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

In the EU, in addition to the EU Marketing Authorisation Application (MAA) of medicines for human use via the centralised procedure, specific challenges are related to orphan medicines and medicines developed for use in the paediatric population.

What we offer:

  • Consulting on national or EMA 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
  • Due diligence - evaluation of medicines offered for in-licensing.