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.

Decentralised, Mutual Recognition, National Procedures

We have assisted in obtaining over 150 Marketing Authorisations via National procedure in Europe and CIS regions. We were/are involved in more than 25 Marketing Authorisation procedures of medicinal products via Centralised, Decentralised or Mutual Recognition procedures.

We provide full-scope service of procedure management, starting from the booking of a slot for Decentralised or Mutual Recognition procedures, dossier development, pre-submission assessment, eCTD compilation and submission to competent authorities, support in preparing responses to deficiencies reported by the Competent authorities, full support during CHMP and CMDh referral procedures, until the granting of Marketing Authorization.

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