platoseedplatoseed
AI-Native FDA Regulatory Services
Panacea provides AI-native FDA regulatory services for Biotechs and Medical Device companies. We hire the most experienced FDA consultants in the industry (ex-FDA, decades of experience, hundreds of filings) and pair them with our AI platform to enable the fastest and lowest cost pathway to FDA approval. While other regulatory consultants bill hourly, our pricing model is simple: fixed, outcome-based pricing. Payment is only due when milestones are complete. We support all FDA regulatory pathways including IND, NDA, BLA, ODD, Pre-Subs, 510(k), De Novo, PMA, IDE, BDD, etc.
Panacea positions itself as an AI-native FDA regulatory services provider that combines ex-FDA regulatory expertise with a specialized AI platform to accelerate submissions across multiple FDA pathways. It emphasizes fixed milestone-based pricing, faster timelines, and higher-quality outputs aligned with client incentives.
Panacea blends an ex-FDA regulatory team with an in-house AI platform to accelerate FDA approvals across 510(k), De Novo, PMA, IND, NDA, and BLA pathways. Services include expert-led strategy roadmaps, end-to-end submission support from pre-meeting to final submission, and AI-enhanced workflows to compress timelines while maintaining expert oversight. Pricing is fixed and milestone-based rather than hourly, with deliverables defined upfront.
Who it’s for: Biotech and life sciences companies seeking FDA approvals and regulatory submissions, including device and drug developers that want faster, lower-cost filings with predictable pricing.
mentions of hiring/traction not explicit; references to milestones, client impact, testimonials imply traction
ex-GTM (Partnerships Lead) @ Anterior - backed by Sequoia, NEA and Microsoft AI's CEO. MD, Imperial College Medical School, Imperial College Business School.
Founder & CTO at Panacea (YC P26). Previously AI Platform Engineer at Anterior, building AI infrastructure for health insurers with millions of members. Co-founded Baqi, scaling to $3M+ in transactions and 20+ enterprise partnerships. Built large-scale distributed systems at Bloomberg, leading multi-team regulatory compliance projects. BS/MS in CS and AI from UIC.
The best FDA consultants, paired with AI, for faster & lower-cost FDA filings.
Panacea pairs elite FDA regulatory consultants with an AI platform to accelerate FDA approval for biotech and medtech companies, offering fixed milestone-based pricing to reduce traditional months-long timelines and six-to-seven-figure costs.
▲ 7
Agent Platform for Life Sciences
AI Licensing Agent for Regulated Industries
