Beaufort, LLC, is a contract research organization and consultancy employing regulatory consultants with more than 20 years’ experience who specialize in in vitro diagnostics (IVDs), medical devices, pharmaceuticals, and biologics. We provide a full range of regulatory consulting services to clients in the United States and around the world. Our solid understanding of the global regulatory environment allows us to assist clients in any location. Beaufort clients receive the best total solution for each project because we build our teams with seasoned regulatory experts to match each client’s specialized project needs. Beaufort’s expert regulatory consultants can engage as part of the client’s in-house staff, as the entire regulatory team, as project managers, or provide support as needed.
In Vitro Diagnostics Regulatory Consulting
Beaufort provides IVD companies a full range of regulatory consulting support. No other IVD CRO can boast the level of expertise or global accessibility as Beaufort, LLC. FDA regulatory consulting for U.S. clients and a host of IVD regulatory services for clients around the world include:
- Regulatory strategies
- Device classification
- Predicate device identification
- Pre-IDE submissions and meetings
- Protocol design
- 510(k) submissions
- De Novo submissions
- PMA and PMA supplement submissions
- IDE applications
- 483 letter responses
- Warning letter resolution
- Liaise with FDA and European authorized representatives
- CE marking
- Post-market support
For each type of IVD submission Beaufort can provide statistical support including the development of statistical analysis plans (SAP) and sample size rationales, performing the analysis outlined in the SAP, and interpretation of the statistical results.
Medical Device Regulatory Consulting
From Europe to Asia, the Middle East to North America, top medical device companies around the world rely on Beaufort’s expertise as medical device regulatory consultants. Beaufort provides a full range of regulatory consulting support to U.S. and international clients including:
- Regulatory strategies
- Device classification
- Predicate device identification
- Pre-IDE submissions and meetings
- Protocol design
- IDE applications
- 510(k) submissions
- De Novo submissions
- PMA and PMA supplement submissions
- FDA-483 letter responses
- Warning letter resolution
- Medical device reporting
- Liaise with FDA and European authorized representatives
- CE marking
- Post-market support
For each type of medical device submission, Beaufort can provide statistical support including the development of statistical analysis plans (SAP) and sample size rationales, performing the analysis outlined in the SAP, and interpretation of the statistical results.
Pharmaceutical Regulatory Consulting
Beaufort offers a broad range of pharmaceutical consulting services for regulatory strategy and compliance in multiple therapeutic areas. Our regulatory consulting services include:
- Regulatory strategies
- Pre-IND submissions and meetings
- Protocol design
- IND applications
- NDAs, aNDAs
- 505(b)(2)s
- Orphan drug applications
- Liaise with FDA and European authorized representatives
- Annual reports
- Post-market support
Biologics Regulatory Consulting
Building a sound regulatory strategy can be a challenging endeavor, especially for emerging biologics companies. Beaufort helps develop and implement customized regulatory strategies designed to optimize the development of biologics. Our regulatory services include:
- Regulatory strategies
- Pre-IND meetings
- Protocol design
- INDs
- BLA and BLA supplement submissions
- Liaise with FDA and European authorized representatives
- Annual reports
- Post-market support
