Chorah Labs offers a regulatory operating system designed for modern biotech companies to create, verify, and track FDA submission packages. The platform uses AI‑driven knowledge graphs to dynamically assemble documents, while built‑in expert review and immutable audit trails ensure full provenance and compliance. It streamlines the entire submission workflow, providing biopharma teams with a single, accountable system for regulatory filings.
Funding
Funding not disclosed
Founders
Product
Problem
Biotech companies face lengthy, error‑prone regulatory submission processes due to fragmented document management, lack of traceability, and manual validation steps, which can delay approvals and increase compliance risk.
Solution
Chorah Labs offers a regulatory operating system that converts submission content into a structured, AI‑driven knowledge graph, enabling dynamic assembly of complete packages. The platform automatically extracts clauses, generates cryptographic hashes, and records each action in an immutable log, providing full document provenance. Real‑time expert validation is integrated into the workflow, ensuring critical outputs are reviewed and approved before finalization. Built on FDA‑grade infrastructure, the system supports 21 CFR Part 11 electronic signatures and deterministic tracking, reducing ambiguity and accelerating the path to regulatory approval.
Target Audience
Primary users are regulatory affairs teams, submission managers, and compliance officers within biopharma and biotech companies preparing FDA or equivalent agency filings.
Features
- AI‑powered knowledge graphs that correlate submission fragments into a coherent, searchable logic model
- Automated clause extraction, MD5 hashing, and hash‑chain sealing for cryptographic integrity of every document
- Real‑time routing of outputs to domain experts for review and approval within the same platform
- Immutable audit trail capturing timestamps, actions, and decision provenance for full regulatory compliance
- Built‑in support for 21 CFR Part 11 electronic signatures and deterministic document tracking
- Modular interface for assembling, updating, and versioning submission packages without manual reassembly