Rhizome
Rhizome AI is a regulatory intelligence platform for life sciences companies that answers complex FDA and EMA compliance questions by searching primary source databases and generating cited, draft briefings. The platform synthesizes information from ICH guidelines, EMA scientific guidance, and EudraLex, and can draft findings into complete documents such as protocol skeletons or slide decks. It is designed to handle multi-agency questions, such as designing a Phase 1 oncology trial that satisfies both FDA and EMA expectations.
- Regulatory & Compliance Technology
- Artificial Intelligence
- Data & Analytics
- AI Agents
- Software Only
- Biotechnology
- Drug Discovery & Therapeutics
- Healthcare Technology
Funding
Raised to date
$500KRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Founder details are not available yet.
Product
Problem
Life sciences companies face the complex and time-consuming challenge of navigating and synthesizing regulatory requirements from multiple agencies, such as the FDA and EMA. This process involves searching through vast, disparate sources like ICH guidelines, EMA scientific guidance, and FDA reports, making it difficult to ensure a comprehensive and accurate understanding of the current regulatory landscape.
Solution
Rhizome AI provides a platform that answers regulatory questions by searching source databases and generating cited, draft briefings. The platform synthesizes information from a wide range of primary sources, including ICH guidelines, EMA scientific guidelines, and EudraLex, while also cross-referencing secondary reporting to provide a comprehensive view. It delivers a complete answer with citations, and can draft the findings into a full document, such as a protocol skeleton or slide deck, ready for review. The service is designed to handle complex, multi-agency questions, such as designing a Phase 1 oncology trial that satisfies both FDA and EMA expectations.
Target Audience
Regulatory affairs professionals, clinical development teams, and life sciences companies that need to understand and comply with complex regulatory requirements from agencies like the FDA and EMA.
Features
- AI-powered search and synthesis of regulatory source databases, including ICH, EMA, and EudraLex
- Generates cited answers with source references, enabling verification and auditability
- Drafts complete regulatory briefings and documents, such as protocol skeletons and slide decks, from the generated answers
- Provides a live, interactive run-through of the search and drafting process, showing the source data used
- Includes a privacy policy that ensures user data is not used to train AI models and is processed solely to generate answers