BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
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​FDA-Accredited 510(k) Review

  • We are accredited to review Class I/II IVD devices for Clinical Chemistry, Hematology, Immunology, Microbiology, Pathology, and Toxicology.
  • We help our clients get their devices approved in ~65 days
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Consulting Services

Pharma, Biotech 

  • Device strategy for biomarkers and precision medicine (PM)
  • Guide decision making to pursue IVD manufacturer or LDT as CDx provider
  • Qualify, negotiate, and manage third party laboratory and IVD partners ​​

Clinical Laboratories

  • Guide startups from plan to operation, including obtaining required certifications and accreditation
  • Direct CLIA labs with different specialties nationwide
  • Enable established organizations to introduce new lines of service

Investors & Tech Appraisers

  • Evaluate Diagnostics and Drug candidates for investment, asset prioritization, and mergers & acquisitions.
  • Evaluate tech’s unmet need, landscape and market opportunities
  • Guide establishing competitive product target profiles and pricing
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All Rights Reserved.
  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us