Gap Analysis of US/other 3rd country dossiers and older dossiers for suitability for submission in Europe

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 Europe 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 Europe may require updating and revamping for submission into new countries via EU MRP or as entirely new National submissions

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

  • Review FDA or other country dossiers or older European 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 Competent Agencies in Scientific Advice
  • Support or guide clients through the Agency dialogue procedure
  • Help with the compilation, publishing and submission of the MAA including re-submission of EU dossier to MHRA for CAP conversion

What our clients say

Search Real Regulatory