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)

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.

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.