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
Foundation model vBx-1.0 for precision neurology
Multimodal patient brain dataset: 12,000+ brains, 6,000 patients
Paired proteomic, genomic, and clinical data per patient
Physical inventory of 900+ frozen brain tissue samples
Virtual biopsy model predicts brain activity from blood draw
Target discovery from proprietary human data
Target characterization with 83% preclinical validation rate
Biomarker identification for clinical trials
Patient stratification for trial enrichment
Lifts responder fraction from 52% to 69% (vBx-1.0)
Reduces trial enrollment by 43% in Parkinson's (L-DOPA responders)
Platform for target discovery, characterization, biomarkers, and stratification
Supports Parkinson's, Alzheimer's, and other neurodegenerative diseases
Partnership model with top-20 pharma collaborations
