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.

Regulatory Affairs Support in Europe


Local Regulatory Affairs Representation

Biomapas provides local regulatory affairs support to clients in both pre-authorization and post-authorization regulatory affairs across Europe. Our full range of Regulatory Affairs solutions is dedicated to delivering the highest quality support, assistance and regulatory approvals for our clients. We employ fast, efficient, and cost-effective working practices.


We have assisted our clients in obtaining over 150 Marketing Authorizations via National Procedures in Europe and CIS regions. During the past few years, we have performed more than 1,000 regulatory submissions. We were/are involved in more than 25 Marketing Authorization Procedures of Medicinal Products via Centralized, Decentralized or Mutual Recognition Procedures. Full Biomapas expertise is listed here.

Geographical Coverage

The detailed list of our geographical coverage is presented below (office locations highlighted):

Albania Finland Luxembourg Serbia
Austria France Macedonia Slovakia
Belgium Germany Malta Slovenia
Bosnia and Herzegovina Greece Moldova Spain
Bulgaria Hungary Montenegro Sweden
Croatia Italy Netherlands Switzerland
Cyprus Ireland Norway Turkey
Czech Republic Kosovo Poland United Kingdom
Denmark Latvia Portugal  
Estonia Lithuania Romania  

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