Gap Analysis of US and other 3rd country 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.

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

  • Review FDA or other country 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
  • 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