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.

Medicinal Product Lifecycle Management

Medicinal product lifecycle management is defined as the process of managing the entire lifecycle of the product. This includes its clinical developmentmarketing authorization and post-authorization activities. As medicinal products that are already marketed change over time, expertise in renewals, variations, and other medicinal product lifecycle management activities is one of the key elements in order to reach the company‚Äôs business goals. Our experienced regulatory affairs team provides medicinal product lifecycle management service to clients across Europe and the former CIS region and offers different solutions according to the scope and extent of the project.

Full Lifecycle Management Service

Biomapas full-scope product lifecycle management service includes but is not limited to:

  • Marketing authorization renewal management;
  • Variation management (type IA, IB, II);
  • Labeling support;
  • Non-EU dossier changes/modifications/amendments;
  • Product line extensions;
  • Product status change (Rx/OTC);
  • Sunset Clause management;
  • Advertising and promotional material review.

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