Rhizome

Rhizome is an AI-powered regulatory research tool designed for regulatory affairs professionals in the life sciences industry, including those at large pharmaceutical companies, clinical-stage biotechs, and independent consultants. It answers regulatory questions by referencing up to 1,000 documents drawn from public health authority databases, with a stated focus on avoiding hallucinations through fine-tuning, grounding, and inference-time checks.

The platform covers a 2.5TB corpus spanning 30 regulatory and clinical datasets across 6 markets, including FDA premarket and postmarket databases, EMA datasets (EPARs, Guidelines, CTIS), and guidance, clinical trials, and SBOAs for additional regions. Each answer includes citations that link directly to specific pages within authoritative source documents.

Core Capabilities

• Answers regulatory questions by citing up to 1,000 documents per query from trusted regulatory and clinical datasets
• Covers datasets across 6 markets, including FDA, EMA, and four additional regions
• Includes a Source Viewer that allows users to jump directly to the cited page within the original document
• Each statement in an answer carries an individual citation traceable to a specific page of an authoritative source
• Reported zero hallucinations in 2025, attributed to fine-tuning, grounding, and inference-time verification methods

Regulatory Datasets Covered

• FDA premarket and postmarket databases
• EMA datasets including EPARs, Guidelines, and CTIS
• Guidance documents, clinical trials data, and SBOAs for four additional regions
• Enterprise tier adds regulatory and clinical databases for South Korea, China, and Japan

Example Research Areas

• FDA positions on real-world evidence and real-world data (RWE/RWD) submissions, including requirements around pre-specified analysis plans, comparator selection, and sensitivity analyses
• Labeling decisions informed by RWE, including limitations such as baseline heterogeneity, missing follow-up data, and selection bias
• Regulatory guidance documents such as FDA Draft Guidance on Safety Reporting, ICH E6(R3), and ClinicalTrials.gov Results Rule

Pricing Tiers

1. Project — $400/month; includes all FDA premarket and postmarket databases, all EMA datasets, and guidance for four additional regions; credit card payment accepted
2. Professional — $3,500/year; single-seat access to the same database set as Project tier; credit card payment accepted
3. Business — $20,000/year; five seats, all professional-tier databases, monthly office hours, and invoice-based pricing
4. Enterprise — custom pricing; five seats, all business-tier benefits, additional databases for South Korea, China, and Japan, and biweekly office hours

Rhizome is backed by Y Combinator and serves more than 20 customers. It is used by regulatory affairs managers, VPs of regulatory affairs, device engineers, and independent regulatory consultants across clinical-stage and commercial organizations.