Dossier Pre-submission Assessment

The dossier pre-submission assessment consists in a critical, objective, scientific and written analysis of your medicinal product documentation. Scientifically assessed dossiers lead to faster and easier registration processes and increased speed to market.

Our internal and external experts can perform an assessment of your dossier, identify possible gaps and weak points, propose appropriate solutions and update the required parts accordingly. In particular, we assess the following parts of your dossier:

  • Non-clinical and Clinical Summaries
  • Overviews (Modules 2.4-2.7)
  • Quality (Modules 2.3 and 3)
  • Non-clinical and Clinical safety and efficacy data (Modules 4 and 5)


For any inquiry regarding our services, please contact Biomapas Business Development team.