Token Factory

SubmissionAI

Data provenance & compliance automation for Phase 2→3 transitions

About this project

A five-agent system that automates regulatory compliance for pharmaceutical IND submissions, targeting the Phase 2→3 transition where 70% of programs fail. Deploys LangGraph agents (Content Analyzer, Data Provenance Tracker, SAP Validator, FDA Conformance Checker, Report Generator); a synthetic Phase 3 trial reached 94% compliance in under 60 seconds. Submitted to the NextGen BioAgents Hackathon (Nucleate NY × Nebius, Jun 2026).

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Technologies

biohack

bioagents

hackathon

regulatory