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Average Ratings 0 Ratings

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features
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support

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Description

RegPass™ serves as a compliance co-pilot designed to amplify your team's effectiveness tenfold. It seamlessly integrates every phase of the regulatory change lifecycle, from horizon scanning to assurance: Horizon Scanning → Rules Inventory → Policies & Controls → Regulatory Policy Advisor. With extensive global coverage and smart Business Profiles that tailor alerts to what matters most, you can remain proactive. Our enhanced Rules Inventory streamlines overlapping obligations into clear, canonical forms for better traceability and understanding. At the core of RegPass is AI, which extracts, ranks, and aligns obligations to your existing policies and controls, providing thorough justification for each recommendation. Every recommendation is well-documented, auditable, and primed for your approval. Developed by the specialists at Braithwate, RegPass encapsulates years of regulatory change knowledge into a dynamic knowledge graph. With its open, extensible, and inherently transparent design, RegPass ensures complete traceability, enabling teams to operate more efficiently, minimize risk, and bolster compliance. By leveraging such a powerful tool, organizations can navigate the complexities of regulatory landscapes with confidence and clarity.

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 Yes 

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

No price information available.
Free Trial No 
Free Version No 

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

RegPass

Founded

2019

Country

United Kingdom

Website

www.regpass.ai

Vendor Details

Company Name

Rimsys Regulatory Management Software

Founded

2017

Country

United States

Website

www.rimsys.io/products/rimsys-platform

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