Beaufort LLC is a contract research organization and consultancy that provides regulatory affairs and FDA consulting, quality assurance & compliance, and clinical research services for pharmaceutical, in vitro diagnostics, medical device, and biologics companies.
Regulatory Affairs and FDA Consulting Services:
Learn More >Beaufort, LLC, provides a full range of FDA consulting services utilizing more than 20 years of
experience interfacing with the FDA.
- Overall regulatory project plans and regulatory strategies
- Preparation for and mediation during pre-IDE/pre-IND meetings
- Pre-IDE, 510(k), PMA, PMA, IND, and BLA Submissions; BLA and PMA Supplements
Quality Assurance & Compliance Services:
Learn More >Our quality assurance and compliance services cover all aspects of quality system
development and compliance and include:
- Gap Analysis Programs
- 483 and Warning Letter Responses
- Audit Readiness/Execution
Clinical Research Organization:
Learn More >Our clinical research services for pharmaceutical, in vitro diagnostics, medical device, and biologics companies include:
- Quality Oversight
- Clinical Trial Management
- Monitoring Services
Solutions to Business Challenges
Beaufort works with pharmaceutical, in vitro diagnostics, medical device, and biologics companies to meet industry challenges and overcome unexpected hurdles. Our case studies share examples of how our experience solves client business challenges.
Read regulatory affairs case studies >
