BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
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We Help You Excel

​​​​Placing IVD devices in the market faster and solving critical biomarkers and precision medicine challenges

Accredited reviewer of 510K submissions in behalf of the FDA


  • Fully accredited by the FDA CDRH as a 510(k) IVD Third Party Reviewer - Check the FDA Website for details under our "Global Quality and Regulatory Services" franchise
  • Fast-track device approval by 130+ days (save >65% of FDA review time)
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Our Consulting Services

Many are enthusiastic about biomarkers and precision medicine, but recognizing their challenges and finding creative solutions sets us apart
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Pharma and Biotech

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Clinical Labs

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Investors and Tech Appraisers 

We consult on...
  • Biomarkers: planning, discovery, qualification, and implementation​ 
  • Precision Medicine and Companion Diagnostics  
  • GCP, GLP, QC/QA, and Compliance
  • Data analysis and bioinformatics
  • Assessment of business opportunities
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Copyright ©2018 BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
All Rights Reserved.
  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us