RAMS

RAMS

Emergo by UL
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+

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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.

About

RegAffairs AI is an AI research assistant for regulatory affairs, compliance and product stewardship teams. You ask a regulatory question in plain language and an agent researches it across 1,046 official regulation databases from more than 340 regulators in 43 jurisdictions, covering chemicals, pharma, food, cosmetics, pesticides, biocides, fashion and EHS. The answer comes back in minutes with every claim cited to the exact regulation, annex entry or judgment paragraph, and each citation opens the stored source document. The research trail, every search and document the agent read, is shown on the page, so the work can be checked and handed to legal. Answers come only from the indexed official text; where the record is silent, the answer says so. Typical questions: is a substance still listed or restricted, what changed after the last amendment, how two markets differ, and who has to notify by when. Questions are never used for training.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Regulatory affairs professionals looking for a solution to streamline compliance processes and maintain up-to-date knowledge of global regulatory requirements

Audience

Chemical compliance

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

No images available

Pricing

No information available.
Free Version Not Supported
Free Trial Supported

Pricing

$100/month
Free Version Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Not Supported
In Person Supported

Training

Documentation Not Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

Emergo by UL
United States
www.emergobyul.com/software/regulatory-affairs-management-suite

Company Information

RegAffairs AI
Portugal
regaffairsai.com

Alternatives

Alternatives

Freya

Freya

Freyr Solutions
MedAffairs AI

MedAffairs AI

Accreditation Council for Medical Affairs (ACMA)
Rimsys

Rimsys

Rimsys Regulatory Management Software
Obsidian Monitoring Advisory

Obsidian Monitoring Advisory

Obsidian Technologies Sarl
LICENSALE

LICENSALE

Arazy Group

Categories

Medical Affairs Supported

Categories

Integrations

No info available.

Integrations

No info available.
Claim RAMS and update features and information
Claim RAMS and update features and information
Claim RegAffairs AI and update features and information
Claim RegAffairs AI and update features and information