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features
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Description

RegAffairs AI serves as an advanced research assistant specifically designed for teams involved in regulatory affairs, compliance, and product stewardship. By posing a regulatory query in straightforward language, users can tap into a wealth of information drawn from 1,046 official regulation databases maintained by over 340 regulators across 43 different jurisdictions, which encompass areas such as chemicals, pharmaceuticals, food, cosmetics, pesticides, biocides, fashion, and environmental health and safety (EHS). Within just a few minutes, users receive a comprehensive answer, with each assertion meticulously linked to the precise regulation, annex entry, or judgment paragraph, allowing direct access to the original source document. The research trail is transparently displayed on the results page, detailing every search and document consulted by the agent, facilitating thorough verification and enabling legal teams to take over the findings. The information provided is strictly derived from the indexed official texts, ensuring that if there is no existing record on a matter, the response will clearly indicate that lack of information. Common inquiries include whether a substance remains on the list or is restricted, identifying changes following the most recent amendment, comparing differences between two markets, and determining who is obligated to notify by a certain deadline. Importantly, user questions are never utilized for training purposes, maintaining confidentiality and integrity. In essence, RegAffairs AI is a vital tool for ensuring compliance and navigating the complexities of regulatory landscapes.

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

No images available

Screenshots View All

Integrations

Arena PLM No 
Arena QMS No 
Cortellis No 
ETQ Reliance No 
Microsoft Dynamics 365 No 
PTC Windchill No 
SAP ERP No 

Integrations

Arena PLM Yes 
Arena QMS Yes 
Cortellis Yes 
ETQ Reliance Yes 
Microsoft Dynamics 365 Yes 
PTC Windchill Yes 
SAP ERP Yes 

Pricing Details

$100/month
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 No 
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 No 
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 No 
Webinars No 
Live Training (Online) Yes 
In Person No 

Types of Training

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

Vendor Details

Company Name

RegAffairs AI

Country

Portugal

Website

regaffairsai.com

Vendor Details

Company Name

Rimsys Regulatory Management Software

Founded

2017

Country

United States

Website

www.rimsys.io/products/rimsys-platform

Product Features

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No Alternatives

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