RegKey.ai

Startup

RegKey is an Agentic AI-powered, expert-curated regulatory intelligence platform with human-in-the-loop oversight that streamlines end-to-end pharmaceutical regulatory processes, reducing compliance burdens, accelerating approvals, and increasing efficiency by 90% for pharma, biotech, and medical device companies.

RegKey automates and optimizes the entire regulatory lifecycle from R&D to NDA/BLA submission and post-marketing. It integrates AI-driven automation with human KOL expertise, enabling intelligent document authoring, regulatory form submissions, real-time guidance searches, competitor intelligence, and compliance automation. By reducing manual inefficiencies, minimizing errors, and cutting costs, RegKey accelerates regulatory decision-making and drug approvals.

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