Regulatory Affairs
AI for regulatory affairs and submissions.
Regulatory writing is exact work under a clock. We build the agents that produce the solid first draft so your writers spend their time on the judgment.
A synopsis, an IND module, the response to an agency question. All of it has to be right, and most of it has to be fast. We build agents that produce the first draft and pull the references behind it, so your regulatory writers stop starting from a blank page at 9pm and spend their hours on the calls that need their judgment.
It all runs under the controls a regulated team needs. A named person signs off, the work leaves an audit trail, and we run a 21 CFR Part 11 evaluation of the workflow before we build it.
What we draft
- First-draft synopses and protocol text.
- IND module drafting, with the literature pulls behind it.
- First responses to agency questions, ready for a writer to finish.
One we shipped
A mid-size sponsor put its protocol and regulatory drafting on an Agentic OS. It freed $150,000 of medical-writer time and $50,000 of reviewer time, and returned $280,000 in the first year on a $25,000 build.
Mid-size sponsor. $280,000 first-year saving. $25,000 build.
Where to go next
Regulatory work runs alongside clinical operations and the broader pharma practice, all under the same compliance controls. An AI Audit is where we figure out which document workflow is worth building first.
Common questions
Can AI draft regulatory documents safely?
It produces the first draft and pulls the references behind it. A regulatory writer reviews, edits, and owns the final text. The agent removes the blank page, not the accountability.
How do you handle 21 CFR Part 11?
We put a named person accountable for the output, keep an audit trail, and version the records. We run a Part 11 evaluation of the specific workflow before building it. See our trust and security page for the detail.
15 min. 5-day written diagnosis. No deck.