Centennial’s Pre-Submission Strategy Agent helps you build a smarter, more strategic regulatory roadmap. By analyzing historical FDA decisions, identifying predicate devices, and modeling likely Q-sub questions, this agent supports you in making informed decisions early. Whether you are navigating between 510(k), De Novo, or PMA, or evaluating how best to present novel features, the agent provides AI-enhanced pathway recommendations, risk indicators, and visual logic trees, turning ambiguity into actionable guidance.
