Gap Analysis of US/other 3rd country dossiers and older dossiers for EU suitability

Many US and other 3rd Country companies may have an extensive dialogue with their own country agency during drug development or additionally just with FDA (if Ex-US). In EU EMA and the national agencies do on occasion differ in their requirements. For example, in terms of starting materials, safety reporting during clinical trials and indeed on suitable end points for investigations on a given indication.

Older dossiers already authorised in the EU may require updating and revamping for submission in additional EU countries via MRP or as entirely new submissions

Our EU experts are well placed to perform the following activities:

  • Review FDA or other country dossiers or older EU dossiers for suitability for EU submission
  • Review of each dossier section by subject matter experts
  • Provide a report on any deficiencies in the package
  • Propose what might be needed to fill any gaps
  • Provide technical consultancy
  • Contribute to design and review of studies
  • Help to identify questions for discussion with EU Agencies in Scientific Advice
  • Support or guide clients through the Agency dialogue procedure
  • Help with the compilation, publishing and submission of the EU MAA

What our clients say

Search Real Regulatory