Features
AI-accelerated FDA submission authoring
Regulatory pathway strategy & roadmap
End-to-end submission support (510(k), De Novo, PMA, IND, NDA, BLA)
Pre-FDA meeting preparation and participation
FDA-trained AI for document analysis and drafting
100% expert oversight by ex-FDA consultants
Fixed, milestone-based pricing
Combines human expertise with custom AI tools
Supports medical devices and pharmaceuticals
Timeline compression (claims 60% faster than incumbents)
Dedicated regulatory lead assigned per project
Free initial consultation to scope work
Autonomous hypothesis generation with agentic AI
Multimodal patient data integration (spatial, multi-omics, clinical)
Clinical trial design and patient stratification
Patient and population analytics
Early portfolio decision insights
Patient validation through wet lab infrastructure
Target ID engine distinguishing novel from rediscovery
Collaborative network of 30+ academic centers
Multi-year partnership with Sanofi for custom AI agents
NVIDIA collaboration for biological benchmark testing
Narrows search space in aging research
K Pro connected to front-end user feedback
Support for antibody-drug conjugate development via spatial biology
