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.

Marketing Authorization Holder Service

MARKETING AUTHORIZATION HOLDER SERVICE

Biomapas provides a Marketing Authorization Holder (MAH) service for the registration procedures of medicinal products. This is required then our client is not able to act as the MAH at the time of the procedure initiation. We offer a complete MAH service, including a full Pharmacovigilance system.

MAH TRANSFER PROJECT MANAGEMENT

The MAH transfer can be initiated at the end of the registration procedure. Our Regulatory Affairs team provides full support for the MAH transfer procedure. Upon request of a client, we can remain the MAH for an unlimited period of time.

Biomapas also provides full-scope Marketing Authorization Application procedure management via Decentralised, Mutual Recognition or National procedures.

 

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

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