Regulatory support for Medical Devices and Medicinal Products


We offer a highly qualified service that prioritizes meeting deadlines along with the highest product’ quality audit standards, with the aim of bringing solutions and an excellent assistance to our customers

Regulatory Strategy

We will take into consideration the various regulatory issues and put together a plan that will bring your Medicinal Product or Medical Devices into the target markets. Our regulatory strategy aligns the regulatory activities together with the business strategy, it identifies the important regulatory elements to be addressed and provides overall definition and direction for a successful Marketing Authorization or Notification.


At BMG, we can compile, submit, and manage all your Medical Device notifications/registrations: we cover the entire spectrum of Regulatory Support Services for Medical Devices, in order to get your products marketed in the most stringently regulated countries (LatAm and Europe)

Support and Compliance

BMG provides all its knowledge to provide excellence in our quality and compliance consulting services. The focus on procedures, a risk-based methodology and a control framework have become paramount in the structure of any organization. Improving the quality management of your organization begins with us.

Marketing Authorizations and Life Cycle Management

We work on variations, renewals and maintenance of the eCTD life cycle. BMG specializes in Maintenance of ISO and CE certification. We carry out the Management of MA transfers and associated variations.


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See you at Medlab Middle East!

BMG Regulatory Affairs is excited to be at Medlab Middle East.
Dear partners & peers from all around the world, come and see us in person!

IVDR: Implementación progresiva y extensión de plazos.

El Reglamento sobre productos sanitarios para diagnóstico in vitro, que se aplicará a partir del 26 de mayo de 2022...

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MDR/IVDR: Commission adopts new standardization request

The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) after its initial standardization request was rejected last year.

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About us

María Mercedes Bertoli

Highly skilled and dedicated Regulatory Affairs Professional with strong capabilities and knowledge acquired over nineteen years of experience working for Pharmaceutical Industries and Consulting Companies, in particular in the fields of Regulatory Affairs, Medical Writing, Quality Control, Quality Assurance, and Systems. Passionate professional able to meet Companies' deadlines and expectations while producing high-quality results for clients.

María Laura Gentile

More than 15 years of experience working in regulatory affairs of medical products for in vitro use diagnosis (IVD). Part of the Argentine health authority (ANMAT) for more than 10 years. Specialist in the regulations that regulate the market for medical products in Latin America.

Contact us

Praga - Czech Republic
Buenos Aires - Argentina

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