Panacea

Panacea is an AI-native FDA regulatory team that pairs former FDA reviewers with a specialized AI platform to accelerate approvals across 510(k), De Novo, PMA, IND, NDA, and BLA pathways. It's built for medical device and pharmaceutical companies that want a hands-on partner to handle the entire regulatory process—from strategy to submission—without the unpredictability of hourly billing. The team includes ex-FDA experts like Dr. Jin Zhang, PhD, a former FDA Lead Reviewer, who bring decades of regulatory experience to every project. The service model is end-to-end: expert-led strategy and roadmap definition, pre-FDA meeting preparation and participation, full submission authoring, and final filing. The FDA-trained AI is purpose-built for regulatory workflows, automating document analysis and drafting to compress timelines while experts maintain 100% oversight. Panacea claims to deliver submissions 60% faster than traditional firms, and its track record includes complex devices like a PMA for a hepatic vascular radioembolization device, a De Novo for radiology AI software, and a 510(k) for neurological surgical planning software. Pricing is fixed and milestone-based—no hourly billing. You pay only when defined deliverables are completed, which aligns incentives with your goals. This makes costs predictable for budgeting, though you'll need a free consultation to get a specific quote. The firm supports all device classes and pathways, from early-stage strategy through approval. Panacea positions itself as a modern alternative to traditional regulatory consultants, who often bill by the hour and benefit from longer timelines. With its blend of regulatory expertise and AI efficiency, it's especially suited to startups and scale-ups that need speed, quality, and cost certainty in FDA submissions.