Pharma regulatory & medical affairs

Regulatory and medical-affairs teams are the bottleneck and the safeguard for everything from label changes to medical-information responses. The work is high-stakes, slow, and dominated by repeated assembly: pulling clinical trial data, reconciling against the current label, drafting the response, routing for sign-off.

Generic LLMs cannot be trusted with anything that lands on a label or a regulator's desk. The industry has spent two years burning credibility on PoCs that did not survive medical-legal review, leaving the team more skeptical of AI, not less.

• iWhich of your document types can be drafted autonomously with med-legal review at the end, and which need assistance only?
• iiHow do we keep the agent grounded in your current label, your current clinical evidence, and the live regulatory guidance?
• iiiWhat does the human-in-the-loop control look like for your medical-affairs reviewer — inside the surface they already use?
• ivHow do we shorten cycle time without compromising the review quality your med-legal team will sign off on?

We deploy therapeutic-area-tuned agents that draft against the current label, current evidence, and current guidance, with explicit traceability for every assertion. The medical-affairs reviewer edits, signs off, and lives in the same surface they already use. Speed comes from removing the assembly work, not from skipping the review.

We have shipped agents that medical-legal teams trust enough to sign off on — which is the only meaningful bar. Our pods include former regulatory-affairs operators, not just engineers; we know which corners are safe to compress and which are not.