Rhizome AI is a regulatory intelligence platform that uses artificial intelligence to answer complex regulatory questions for life sciences companies. It searches source databases, generates cited answers, and drafts complete regulatory briefings, streamlining the process of navigating requirements from agencies like the FDA and EMA.
Funding
Funding not disclosed
Founders
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 often 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.