BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
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We Help You Excel

Biomarkers and Diagnostics Consulting, LLC ​empowers client utilization of biomarkers and diagnostics in drug development and patient management.  Over 25+ years, we have helped the industry achieve the ideal trifecta: quality, efficiency, and cost-effectiveness. 

We assist....
  • Pharmaceutical and Biotechnology Companies (Oncology, immunology, cardiovascular, metabolic)
  • Clinical Laboratories​
  • Investors and Tech Appraisers​​

We consult on....
  • Biomarkers: planning, discovery, qualification & implementation​ 
  • Prcciion Medicine 
  • GCP, GLP, QC/QA & Compliance
  • Data analysis & bioinformatics
  • Assessment of business opportunities
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We achieved....  
  • 120+ successful consultations and 35+ full-scale projects for our clients
  • 2 FDA-approved drugs
  • 5 FDA approvals of high complexity IVD devices
  • 120+ PI-PIV clinical trials
  • 35+ drug development programs in immuno/oncology, cardiovascular, immunology, diabetes, and atherosclerosis
  • 7 oncology CDx programs; from strategy to PMA
  • 10+ due diligence initiatives for M&A, investment and licensing opportunities
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All Rights Reserved.
  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us