AI-native FDA regulatory services combining ex-FDA consultants with specialized AI tools on fixed milestone-based pricing with no payment until deliverables…
Panacea pairs ex-FDA regulatory consultants (including former FDA Lead Reviewers and Team Leads) with a custom AI platform built for FDA regulatory workflows to deliver faster, higher-quality submissions. Pricing is fixed and milestone-based with no upfront fees and no hourly billing. The service covers 510(k), De Novo, PMA, IND, NDA, BLA, IDE, and ODD pathways, from pre-submission strategy and FDA meeting preparation through full authoring, submission, and post-submission support. Panacea targets life sciences and medical device companies seeking an AI-accelerated path to FDA approval. Panacea is a product of Panacea.