ProcEdge RIMSSarjen Systems Pvt Ltd
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RAMSEmergo by UL
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About
ProcEdge RIMS is a centralized regulatory information management system designed to streamline global product registration and post-registration activities. It replaces error-prone manual methods like Excel with a unified platform that offers real-time access to product data across departments. The system tracks submissions, renewals, and regulatory correspondence with configurable workflows and automated reminders to ensure compliance with varying international regulations. It supports industry standards such as IDMP and meets GxP, GDPR, and 21 CFR Part 11 compliance requirements. By consolidating regulatory data and workflows, ProcEdge RIMS helps companies reduce operational costs and speed up time to market. Its robust query management and audit trail features improve submission quality and regulatory responsiveness.
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About
Emergo by UL's Regulatory Affairs Management Suite (RAMS) is a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for medical device and in vitro diagnostic companies. Leveraging decades of regulatory compliance expertise, RAMS offers a suite of tools to navigate the complex and evolving landscape of global medical device regulations. Key features include product classification, which guides users through a series of questions to determine or verify device classification, and Smart Builder, a tool that provides step-by-step guidance and templated text to create accurate regulatory documentation, facilitating smoother device registration and faster market access. The Registration Tracker automates the tracking of global registrations and certifications, helping organizations avoid missed renewals and maintain compliance.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Regulatory affairs professionals and compliance teams in pharmaceutical, biotech, and healthcare industries seeking a centralized, compliant platform to manage global product registration and regulatory information efficiently
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Audience
Regulatory affairs professionals looking for a solution to streamline compliance processes and maintain up-to-date knowledge of global regulatory requirements
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and VideosNo images available
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Pricing
$300
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationSarjen Systems Pvt Ltd
Founded: 1998
India
rims.sarjen.com
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Company InformationEmergo by UL
United States
www.emergobyul.com/software/regulatory-affairs-management-suite
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Integrations
No info available.
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Integrations
No info available.
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