Rhizome

Regulatory affairs professionals at life sciences companies need to know what regulators like the FDA and EMA require or have said on specific topics, such as how to design a Phase 1 oncology trial that satisfies both agencies. Today this means manually searching ICH guidelines, EMA scientific guidelines, EudraLex regulations, FDA guidance documents, and secondary sources like RAPS and DIA reporting, then synthesizing scattered and sometimes non-primary information into a coherent answer. This is slow and risks missing procedural or scientific divergences between agencies, or relying on secondary reporting when primary guidance text is unavailable. A regulatory affairs manager quoted on the site says she would cry if she lost access to the tool, suggesting the manual alternative is painful enough to make the product highly valued.

Rhizome is an AI tool that answers regulatory questions by searching indexed health authority databases (118.1 million pages across 17 countries as of the page's description) and generating answers with up to 1,000 citations per response, each tied to a primary source document. It demonstrates this by taking a real question about designing a Phase 1 oncology trial compliant with both FDA and EMA, reading 298 sources across ICH guidelines, EMA scientific guidelines, EudraLex Volume 10, and CHMP/SAWP records, then producing a structured, cited briefing document covering starting-dose rationale, trial design, and escalation methodology. The tool explicitly flags when a claim rests on secondary reporting (such as RAPS or DIA) rather than an agency's own primary guidance text, which the company positions as part of its hallucination-free, traceable approach. Outputs can be exported into a full document for further use, such as drafting a briefing or protocol skeleton.