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Regulatory Strategy & Submissions

NextPhaseDx provides clear, practical regulatory guidance to help diagnostic developers plan and execute successful pathways to FDA clearance. We integrate scientific, analytical, and quality perspectives to ensure your submissions meet both regulatory expectations and commercial timelines—from pre-submission planning through final EUA, De Novo, 510(k) or PMA delivery.

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NextPhaseDx also supports SBIR and STTR-funded programs as a small business prime or regulatory partner to streamline documentation, engagement, and submission planning.

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Our Expertise

We combine hands-on experience with evolving FDA and international standards to keep your diagnostic programs compliant, audit-ready, and positioned for approval.

  • Regulatory strategy and pathway planning for RUO-to-IVD transitions

  • Support for FDA Q-Submissions and early regulatory engagement

  • Guidance on analytical and clinical study design to support PMA, 510(k), De Novo, or EUA submissions

  • Preparation and organization of FDA submission-ready documentation 

  • Coordination with cross-functional teams to align technical, quality, and regulatory deliverables

Whether you’re mapping your first regulatory pathway or preparing for formal submission, NextPhaseDx provides the insight, structure, and documentation expertise to navigate the FDA process with confidence.
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