Beaufort, LLC, is a contract research organization and consultancy dedicated to accelerating medical innovation in partnership with our clients in the pharmaceutical, in vitro diagnostics, medical device, and biologics industries. Our range of highly customizable services includes FDA regulatory consulting, clinical research, clinical trial monitoring, quality assurance & compliance, and quality oversight.
Our Team of Experts
Our experts average more than 20 years of service in the healthcare industry. Beaufort’s expertise with clinical research, FDA quality system regulations, and FDA regulatory consulting provides our clients with unmatched experience to meet the challenges of the global healthcare industry.
- John Wilson, Ph.D: Clinical Research expert with more than 30 years of experience who heads up our clinical trial monitoring and quality oversight programs
- Kennon Daniels, Ph.D: FDA regulatory consulting expert with more than 10 years experience in research and regulatory affairs
- Anne Zavertnik: FDA regulatory and quality & compliance expert with more than 20 years of experience in the medical device and in vitro diagnostics industries
- Teresa Hedrick, MT (ASCP), CCRC, CCRP: Medical technologist with more than 25 years of combined experience in research and clinical trial management
FDA Relationship
Beaufort, LLC, helps clients manage FDA interactions and mediation to gain needed approvals. We have experience handling several types of FDA regulatory consulting including:
- Responding to both FDA 483 and Warning Letters
- Mediation with FDA regarding 510(k) and pre-IDE submissions
- Feedback on final product labeling and potential pitfalls
Why Choose Beaufort LLC?
Beaufort’s team of experts helps clients manage the complexities of FDA regulations and the clinical research environment. We are a niche CRO with the flexibility to customize solutions for every client while drawing on our global experience.
Beaufort LLC gives our clients the best solutions that leverage key competitive advantages.
- Superior Clinical Research Programs
- Enhanced Regulatory Development
- Exceptional Quality Systems
