We're building the regulatory infrastructure biotech actually needs.
Chorah Labs is a regulatory technology company founded by biopharma operators who lived the problem firsthand. We build systems that turn regulatory work into structured, auditable, and accountable workflows — so promising therapies reach patients faster.
We lived this problem
While managing cell and gene therapy programs at a CDMO, we watched promising therapies stall, not because of bad science, but because of documentation bottlenecks, slow review cycles, and regulatory context lost during tech transfer.
We built internal tooling to fix it, accelerating knowledge transfer and cross-functional sign-off workflows, cutting review cycles by 30%. But those tools stayed locked inside one organization.
We started Chorah Labs because the entire industry has this problem
Early-stage biotech teams face the same regulatory burden as Big Pharma, but lack the resources, systems, and institutional knowledge to manage it. They spend 30-40% of their time on regulatory documentation and still face preventable delays.
The industry doesn't need another document generator.
It needs regulatory infrastructure, purpose-built by people who understand both the technical and regulatory constraints.
Why We're Different
Our closest competitors are well-funded startups founded by software engineers building document automation for regulatory teams. We're building from operational reality.
We've managed the programs. We've sat through the tech transfers where no one knew why a decision was made. We've watched context evaporate across team changes and vendor handoffs. We know where workflows actually break, where knowledge gets lost, and where regulatory risk concentrates.
That's why ARI isn't another AI writing tool. It's regulatory infrastructure — with audit trails, decision traceability, expert validation, and workflow orchestration designed into the foundation.
Let's talk about your workflows
Whether you're preparing your first IND or scaling across multiple programs, we'd like to understand your process — and show you what governed regulatory infrastructure looks like.