What Panacea does
Panacea provides AI-native FDA regulatory services, combining experienced regulatory professionals with purpose-built AI tooling. It supports companies through FDA pathways including 510(k), De Novo, PMA, IND, NDA, and BLA submissions, from early strategy through final filing.
Key capabilities
- Regulatory strategy and pathway selection
- End-to-end submission support from pre-meetings through filing
- AI-accelerated workflows built specifically for regulatory tasks
- Milestone-based fixed pricing rather than hourly billing
Who it's for
Panacea serves life sciences and medical device companies, from early-stage through active submission phases, seeking to reduce regulatory risk and move through FDA approval faster. By pairing AI tools with experienced regulatory professionals, the company aims to cut the manual work in traditional regulatory consulting while maintaining accuracy across submissions, ultimately helping accelerate the path to bringing medical innovations to patients in the AI healthcare space.