Strategic Regulatory

Regulatory Program Development

In an ever-changing and complex Regulatory environment, the challenges to bringing a new medical product to market can seem overwhelming.  Innovative medical products require innovative regulatory strategies to obtain regulatory clearance or approval in a complex global market. We will partner with you to align your business objectives and market plans, with an efficient and effective regulatory strategy.

With the  many innovative technology options in medicine today, determining if a new idea is considered by Regulatory authorities as a drug, a biologic, a device, or a combination can be challenging.  The steps to market include answering several questions outside of the product development process, including:

  • What is the most appropriate path to market, and do I have options?
  • What is the product classification?
  • How will my product be regulated?
  • What are the pre-clinical test requirements?
  • What are the Quality System requirements?
  • Will this product require a clinical trial?

We can help answer those questions and more.  We advise clients on all aspects of regulation involving the U.S. Food and Drug Administration (FDA), the European Union, and other local, national, and international regulatory entities.

The Consulting Services group at BBA provides comprehensive regulatory assessments, based on your technology and possible product indications.  When ready, we will guide the submission development process and partner with you during communications and submission development to the regulatory bodies.

BBA’s senior regulatory team members have extensive experience communicating with all branches within CDRH of the FDA, including the office of the FDA Ombudsmen, Notified Bodies and other regulatory agencies. Our experience and regulatory knowledge can be combined to help you successfully negotiate with the regulators to come to an agreeable outcome for your submissions.

The Boston Biomedical Associates team was instrumental in their support of AtriCure in executing our ABLATE trial, interacting with the FDA and preparing for the panel meeting. We are impressed with their extensive clinical and regulatory expertise as well as their professionalism and appreciate their support in working with us to achieve a positive panel vote.
— David J. Drachman, Former President and Chief Executive Officer of AtriCure, Inc.

Our dedicated team will help you achieve your unique vision

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