Regulatory and Funding Strategy for Infectious Disease Diagnostics
Helping in vitro diagnostic companies secure non-dilutive government funding and translate it into FDA-ready submissions.
Services
Funding-Ready Regulatory Strategy
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Early regulatory planning aligned with NIH, DoD, BARDA, and other agency expectations.
Grant-Aligned Development Support
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Designing studies, milestones, and deliverables that satisfy both funders and FDA.
FDA Submission & Agency Support
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De Novo, 510(k), CLIA Waiver, Dual Submission, EUA, and pre-submission support built on funded, submission-ready evidence.
Schedule your appointment
IVD Consulting LLC offers a complimentary consultation to discuss your in vitro diagnostic program, regulatory goals, and funding strategy. We’ll review where you are in development, identify potential regulatory and funding considerations, and explore how we could work together to support FDA submission readiness and milestone achievement.