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features
design
support

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Write a Review

Description

Rhizome serves as an AI regulatory collaborator specifically designed for teams in the life sciences sector. While general AI assistants offer remarkable capabilities, there are distinct requirements for an AI tool that aids in making decisions regarding drugs or devices worth over $100 million. Our agents are strictly limited to referencing facts derived from primary source documents, ensuring that nothing is validated based on agent memory; we assess their performance based on this criterion, and there have been no instances of inaccuracies reported in the past 18 months. The databases that underpin regulatory decisions, including Drugs@FDA, guidance documents, clinicaltrials.gov, and various standards, often exist in formats that are not easily searchable by computers, with a significant amount being image-only PDFs. We have developed the ability to ingest and process all of this information, encompassing over 75 health authority databases across more than 12 markets as of August 2026, with this number continually growing. This equates to over 45 million documents that our agents can query comprehensively. In contrast to a general assistant, which typically references 5 to 10 sources, Rhizome is capable of examining hundreds to thousands of documents, as the essential question is often, "Did we overlook a precedent?" This thorough approach ensures that our users are equipped with the most comprehensive and accurate information possible.

Description

Rimsys provides a single, cloud platform for end-to-end regulatory process digitization and automation. Designed by and for regulatory affairs professionals, Rimsys helps medtech companies reduce repetitive administrative work, speed time to market, respond faster to changing regulations, and drive alignment across internal teams, affiliates, and partners. Only Rimsys provides a holistic platform that supports a full range of regulatory activities. Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions. Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions. Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes. Get notified of changing standards, laws, regulations, and guidance documents that impact your products. Create self-service application, product, and country reports to see exactly where your products can be sold and their current registration status.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Arena PLM No 
Arena QMS No 
ChatGPT Yes 
Claude Yes 
Cortellis No 
ETQ Reliance No 
Microsoft 365 Copilot Yes 
Microsoft Dynamics 365 No 
PTC Windchill No 
SAP ERP No 

Integrations

Arena PLM Yes 
Arena QMS Yes 
ChatGPT No 
Claude No 
Cortellis Yes 
ETQ Reliance Yes 
Microsoft 365 Copilot No 
Microsoft Dynamics 365 Yes 
PTC Windchill Yes 
SAP ERP Yes 

Pricing Details

$0/month/user
Free Trial No 
Free Version Yes 

Pricing Details

We believe that truly centralized information and broad collaboration are key to efficient and effective regulatory affairs. That’s why we developed a holistic platform that organizes all of your regulatory information at the individual product level and a pricing model that isn’t tied to individual user seats.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Rhizome AI

Founded

2023

Country

United States

Website

rhizomeai.com

Vendor Details

Company Name

Rimsys Regulatory Management Software

Founded

2017

Country

United States

Website

www.rimsys.io/products/rimsys-platform

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