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Funding-Ready Regulatory Strategy

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Early regulatory planning aligned with NIH, DoD, BARDA, and other agency expectations.

Early regulatory planning aligned with NIH, DoD, BARDA, and other agency expectations.

Funding-Ready Regulatory Strategy is ideal for early-stage and growing diagnostic companies that need clarity on regulatory expectations, want to strengthen funding proposals, and aim to use limited resources strategically to reach FDA milestones.

This service focuses on device classification, defining the appropriate regulatory pathway, selecting a predicate and outlining the verification and validation requirements to showcase a strong understanding of the product development pathway and to guide proposal development.

We help translate regulatory requirements into fundable executable development plans that support grant applications, contracts, and early-stage investment.