Marketing Authorization Applications

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. 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.