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What is Rimsys?
Rimsys offers a comprehensive cloud-based platform specifically designed for the complete digitization and automation of regulatory processes. Tailored by regulatory affairs experts for their peers, Rimsys enables medtech companies to minimize repetitive tasks, accelerate their market entry, swiftly adapt to evolving regulations, and enhance collaboration among internal teams, partners, and affiliates.
What sets Rimsys apart is its all-encompassing platform that facilitates a wide array of regulatory activities. Users can leverage regulatory intelligence along with digital templates to refine their regulatory strategies and simplify submission processes. The platform allows for the creation of compliant, submission-ready documentation and the consolidation of PDF packages for both electronic and print submissions. Moreover, it enables users to digitally gather and uphold evidence of compliance while linking to pertinent standards and receiving alerts about any changes. Rimsys ensures that users stay informed about modifications in standards, laws, regulations, and guidance documents affecting their products. Additionally, the platform offers the ability to generate self-service reports on applications, products, and countries, allowing users to track where their products can be marketed and their current registration statuses, thus further enhancing regulatory efficiency.
What is Rhizome AI?
Rhizome functions as a collaborative AI regulatory partner specifically tailored for teams working within the life sciences industry. Although conventional AI assistants boast impressive features, the unique demands of an AI tool tasked with guiding decisions on drugs or devices valued at over $100 million necessitate a more specialized approach.
Our agents exclusively rely on factual information extracted from primary source documents, guaranteeing that their validation does not come from memory; we evaluate their effectiveness based on this standard, and there have been no reported inaccuracies in the last 18 months.
The foundational databases that inform regulatory choices, such as Drugs@FDA, guidance documents, clinicaltrials.gov, and various standards, often present challenges for computer searches, with many existing solely as image-based PDFs. We have successfully developed methods to ingest and analyze this vast array of information, which includes over 75 health authority databases across more than 12 markets as of August 2026, a figure that continues to expand. This translates to more than 45 million documents that our agents can access and query in depth.
Unlike a general assistant that may only consult 5 to 10 sources, Rhizome has the capability to analyze hundreds or even thousands of documents, as the crucial inquiry often posed is, "Have we missed a relevant precedent?" By employing this exhaustive methodology, we ensure that our users receive the most thorough and precise information available, ultimately empowering them to make informed decisions in their critical work. With a commitment to continuous improvement, we consistently enhance our processes to adapt to the evolving landscape of regulatory requirements.
Integrations Supported
Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
Integrations Supported
ChatGPT
Claude
Claude Duet
Claude for Legal
Microsoft 365 Copilot
API Availability
API Availability
Pricing Information
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.
Pricing Information
$0/month/user
Free Version
Supported Platforms
SaaS
Supported Platforms
SaaS
On-Prem
Customer Service / Support
Standard Support
Web-Based Support
Customer Service / Support
Standard Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Rimsys Regulatory Management Software
Date Founded
2017
Company Location
United States
Company Website
www.rimsys.io/products/rimsys-platform
Company Facts
Organization Name
Rhizome AI
Date Founded
2023
Company Location
United States
Company Website
rhizomeai.com
Categories and Features
Regulatory Information Management (RIM)
Not specified
Regulatory Intelligence
Not specified
Categories and Features
Regulatory Intelligence
Not specified