Rhizome AI

Rhizome is an AI-powered regulatory research platform that helps life sciences professionals answer regulatory questions by referencing public health authority databases. The platform is designed to provide comprehensive, citation-backed answers without hallucinations, drawing on a 2.5TB corpus spanning 30 regulatory and clinical datasets across 6 markets. Rhizome serves a broad range of users including large pharmaceutical companies, clinical-stage biotechs, independent regulatory affairs consultants, and device engineers.

The platform has delivered over 2,800 answers to more than 20 customers and is backed by Y Combinator. Each answer cites up to 1,000 documents from authoritative sources, with citations linking directly to specific pages within those source documents to support easy fact-checking.

Core Capabilities

• Answers regulatory questions by referencing up to 1,000 documents per query from trusted regulatory and clinical datasets
• Covers FDA premarket and postmarket databases, EMA datasets (including EPARs, Guidelines, and CTIS), and guidance, clinical trials, and Summary Basis of Approval documents for additional regions
• Provides inline citations for every statement, with each citation linking directly to a specific page in the source document
• Applies fine-tuning, grounding, and inference-time checks to prevent hallucinations; no hallucinations were reported in 2025
• Supports research across topics such as real-world evidence and real-world data submissions, FDA labeling decisions, ICH guidelines, and clinical trial results rules

Data Coverage and Markets

• 2.5TB corpus of regulatory and clinical source material
• 30 regulatory and clinical datasets across 6 markets
• FDA premarket and postmarket databases included in all tiers
• EMA datasets including EPARs, Guidelines, and CTIS included in all tiers
• Guidance, clinical trials, and SBOAs for four additional regions included in standard tiers
• Enterprise tier adds regulatory and clinical databases for South Korea, China, and Japan

Pricing and Plans

• Project ($400/month): Immediate, flexible single-seat access to all FDA and EMA datasets plus four additional regional datasets; credit card payment accepted
• Professional ($3,500/year): Best-value single-seat annual access to the same database coverage as the Project tier; credit card payment accepted
• Business ($20,000/year): Five-seat annual access to all professional-tier databases, monthly office hours, and invoice-based pricing
• Enterprise (custom pricing): Five or more seats with all Business-tier benefits, additional databases for South Korea, China, and Japan, and biweekly office hours

Users and Use Cases

• Used by regulatory affairs managers, VPs of regulatory affairs, directors of regulatory affairs, heads of combination devices regulatory affairs, principal regulatory affairs consultants, and device engineers
• Customers span clinical-stage biotechs, commercial biotechs, top-five pharmaceutical companies, and independent consultants
• Reported use cases include accelerating research that previously took weeks or months, supporting combination product regulatory work, and conducting detailed regulatory landscape reviews

Rhizome positions itself as a research tool where accuracy is the primary design priority, with speed as a secondary benefit. The platform is accessible via credit card for individual users and offers invoice-based and custom arrangements for teams and enterprise customers.