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 
• Fast-track device approval by 130+ days (save >65% of FDA review time)

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Our Consulting Services

Pharma and Biotech

Clinical Labs

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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