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.

Medical Devices and IVD Devices

Biomapas provides full scope regulatory affairs services for Medical Devices and In Vitro Diagnostic Devices. This includes:

  • Clinical Evaluation of Medical Devices;
  • CE Marking Consulting for Medical Devices and IVDs;
  • Guidance on medical device classification;
  • Consulting on the European Medical Devices Directives;
  • Technical File Preparation for Medical Devices and IVDs;
  • Interaction with and documentation preparation for Competent Authorities;
  • Clinical Evaluation Reports for Medical Devices.

Biomapas also offers Clinical Evaluation and Materiovigilance services on Medical Devices.

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