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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.

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 
Cortellis No 
ETQ Reliance No 
Microsoft Dynamics 365 No 
Montrium Connect Yes 
PTC Windchill No 
SAP ERP No 

Integrations

Arena PLM Yes 
Arena QMS Yes 
Cortellis Yes 
ETQ Reliance Yes 
Microsoft Dynamics 365 Yes 
Montrium Connect No 
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 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 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

Montrium

Country

Canada

Website

www.montrium.com

Vendor Details

Company Name

Rimsys Regulatory Management Software

Founded

2017

Country

United States

Website

www.rimsys.io/products/rimsys-platform

Product Features

Document Management

Access Controls No 
Archiving & Retention No 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing No 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management No 
Full Text Search No 
Offline Access No 
Optical Character Recognition No 
Print Management No 
Version Control Yes 

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