Regulatory Affairs

Our full range regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals. We follow the needs of our customer and their portfolios, as we work with a wide range of product categories: medicinal products, medical devices, cosmetics, and food supplements.  Our Regulatory Affairs team has comprehensive expertise and assures quality and accuracy for each task. All team members have majored in life sciences.

Dossier Pre-Submission Assessment

Dossier pre-submission assessment involves 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 parts in need of attention. In particular, we assess the following sections 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.

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