Clinical and Regulatory Services

With Beaufort, your research is directed by industry experts — we know how regulatory expectations are evolving for everything from companion diagnostics to laboratory developed tests and what those expectations mean for your intended outcomes. Our team manages clinical trials from start to finish and provides complete regulatory affairs consulting for even the most complex in vitro diagnostics, companion diagnostics and biomarkers.

Beyond developing strategies for successful product development, Beaufort also focuses on maximizing operational efficiency — that’s the benefit of working with a partner that offers unparalleled technical expertise. For systematic preparation, disciplined execution and straightforward performance visibility, choose Beaufort because we streamline IVD, medical device and pharmaceutical research, development and clearance and approval.

IVD Experience

Beaufort’s expertise includes the following therapeutic areas:

  • Allergens
  • Cardiology
  • Clinical chemistry
  • Diabetes
  • Genetic testing
  • Hematology
  • Immunology
  • Infectious diseases
  • Microbiology
  • Oncology
  • Respiratory diseases
  • Women’s health and prenatal


Our team is also experienced in the following specialty areas:

  • Biomarker development
  • Companion diagnostics
  • Genomic and proteomic testing
  • Home use tests
  • Laboratory tests
  • Molecular diagnostics
  • Point of care tests


Medical Device Experience

Beaufort is experienced in guiding the development of medical device products for the following therapeutic areas:

  • Anesthesiology
  • Cardiology
  • Dental
  • Gastroenterology
  • Neurology
  • Ophthalmology
  • Orthopedics
  • Plastic surgery
  • Pulmonology
  • Radiology
  • Urology
  • Women’s health
  • Wound healing


Read case studies of how Beaufort has helped clients meet their Clinical and Regulatory needs.