Your successful market authorization is our first priority

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Tested and proven regulatory and quality solutions

Achieving regulatory approval and registration requires a partner that brings the right combination of relevant experience, strategic insight, and operational excellence. Our timely and results-driven approach streamlines the regulatory planning and submission process, and helps ensure compliance with all FDA, EMA, and other global regulations and guidelines. 

Learn more about how Beaufort’s team of regulatory and quality experts can deliver a full range of integrated, flexible, and risk-balanced solutions, all designed to effectively and efficiently speed your product to market.

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Regulatory Affairs

Informed, thorough, and end-result focused solutions to accelerate market authorization and commercialization, including:

  • Regulatory strategy and guidance support
  • Protocol development
  • Pre- and post-market submission and support
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Regulatory Affairs Explore Medical Device
Regulatory Affairs
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Quality Assurance

Our unwavering commitment to meeting the highest scientific and operational standards around the globe is backed by well-established systems and processes.

  • Quality management system (QMS) design and implementation
  • On-site gap assessments and remediation
  • Auditing and inspection readiness
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