About NEXTPHASEDX, LLC
NextPhaseDx, LLC is a start-up diagnostics company that provides expert guidance for FDA-aligned in vitro diagnostic (IVD) development, supporting academic and early-stage industry teams through biomarker discovery, assay development, validation, and regulatory submission.
FDA-aligned IVD developmentAssay development and optimizationAnalytical validation planningQuality system implementationRegulatory strategy and pathway definitionFractional leadership and executive guidance
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