In Vitro Diagnostics Experts

Beaufort, LLC, has significant experience with in vitro diagnostics products, including traditional in vitro diagnostic assays, molecular diagnostics and personalized medicine, biomarker development, and conversion of laboratory developed tests (LDTs) to 510(k) submissions or PMA submissions. We provide FDA regulatory consulting, quality assurance and compliance, and clinical research services to companies in the in vitro diagnostics industry.

In Vitro Diagnostics Regulatory Affairs

A sound regulatory strategy provides a foundation for successful healthcare innovation. This is particularly relevant for diagnostics companies that develop highly sophisticated diagnostics products, that face increased regulatory oversight of ASRs and IVDMIAs, or that deal with evolving regulation of home-brew tests and CLIA labs.

Beaufort helps develop and implement customized regulatory strategies designed to optimize the development of in vitro diagnostics products. Our FDA regulatory consulting services include preparing the overall product development plan, creating a customized regulatory strategy, and submission of 510(k)s.

In Vitro Diagnostics Clinical Trials

Beaufort’s clinical research services encompass clinical trial management, clinical trial monitoring and quality oversight. We understand in vitro diagnostics regulation and the design and conduct of diagnostics clinical trials.

As a directed response to FDA quality system regulations, Beaufort is the first IVD CRO to offer quality oversight services. Our high-caliber quality oversight team provides uniform, consistent and quality-focused evaluations.

In Vitro Diagnostics Quality Assurance

Beaufort helps develop, implement and maintain the quality systems essential for diagnostics companies to remain compliant. Whether taking a new product to market or maintaining the quality of an existing product, Beaufort can help design straight-forward, tailor-made quality management solutions.