Accredited reviewer of 510K submissions in behalf of the FDA

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• 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

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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