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Regulatory Strategy & Submissions

Defining and executing FDA-aligned regulatory pathways for diagnostics

NextPhaseDx partners with academic and early-stage industry teams to define appropriate FDA regulatory pathways and align development activities accordingly. Our work focuses on early, well-informed regulatory decision-making that reduces downstream uncertainty and supports efficient progression toward FDA interaction, submission, and review.

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We emphasize regulatory strategies that are grounded in program maturity, intended use, and evidentiary expectations, ensuring that assay development, validation planning, and quality practices remain aligned with the selected pathway throughout development.

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Our Expertise

Applying regulatory judgment and FDA-aligned practices to guide diagnostic programs through key regulatory decisions.

  • Regulatory classification and pathway assessment informed by intended use
  • Alignment of development, validation, and quality activities with regulatory expectations
  • Planning and preparation for FDA interactions, including pre-submission engagement
  • Support for submission strategy and documentation as programs mature
  • Coordination across scientific, quality, and regulatory stakeholders
Whether teams are defining an initial regulatory strategy or preparing for formal FDA engagement, NextPhaseDx provides experienced regulatory judgment and structured guidance to help navigate the regulatory process with clarity and confidence.
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