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Grant-aligned development support ensures that your funded development activities are designed to meet both sponsor expectations and FDA regulatory requirements. We work with you to translate grant aims, milestones, and deliverables into executable development plans that generate data appropriate for FDA submissions, reducing the risk of misalignment between funded work and regulatory needs.
This service focuses on study design, regulatory documentation, and milestone planning for activities such as analytical and clinical validation, performance evaluation, and regulatory interactions conducted under government-funded programs. We help ensure that protocols, reports, and deliverables satisfy funding agency requirements while remaining consistent with FDA guidance, relevant standards, and submission expectations.
Grant-Aligned Development Support is ideal for companies managing NIH awards, DoD or BARDA contracts, or other government-funded programs who want confidence that their funded work will directly support regulatory milestones and future FDA submissions—without unnecessary rework or delays.