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Helping diagnostics companies discover, develop, and commercialize in the U.S. market. Lab testing and in vitro diagnosis consultation
Helping diagnostics companies discover, develop, and commercialize in the U.S. market. Lab testing and in vitro diagnosis consultation
Validate your assumption about your Go To Market Diagnosis strategy, comprehensive analysis and executable plan diagnostics test/kit value proposition.
Select your market segment and build one comprehensive plan from clinical development, through, regulation, and reimbursement. Diagnostic Lab Testing
Evaluate your study design, and clinical setting to obtain human subjects samples and achieve your test/kit analytical and clinical validity. Go To Market Diagnosis strategy, comprehensive analysis and executable plan
Ensure your data plan, and data analysis align with your strategic goal and regulatory submission. Diagnostic Lab Testing Lab testing and in vitro diagnosis consultation
Get an FDA pre-submission meeting to verify your regulatory path and compare it with the
CMS-CLIA alternative. Go To Market Diagnosis strategy, comprehensive analysis and executable plan
Discuss your test/kit clinical utility with payers and LBM to ensure future coverage decisions.
Lab testing and in vitro diagnosis consultation
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