What it sells
AI-Native FDA Regulatory Services
Business model breakdown
Buyer: who owns the budget?
UnverifiedFounder / regulatory affairs head at device or biotech companies
Trigger: what makes them buy now?
Need faster, cheaper FDA approval across 510(k), De Novo, PMA, IND, NDA, BLA
Workflow: what inputs become what output?
Expert strategy and roadmap, pre-submission meetings through authoring and submission, accelerated by FDA-trained AI tools with expert oversight
Economics: what it saves and how it charges
Fixed milestone-based fees (pay when deliverables complete); claims 60% faster than traditional firms
Distribution: how it reaches customers
Book a free consultation / call; customer stories
Funding history and coverage
| Round date | Stage | Amount | Investors | Source |
|---|---|---|---|---|
| — | Y Combinator Spring 2026 | — | Y Combinator | ycombinator.com |
Profiles summarize public reporting and company websites. Business-model notes are MaxBC's reading of that material, not confirmed facts; unknowns are left blank rather than guessed. Updated 2026-10-12.