RAMS

RAMS

Emergo by UL
+
+

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About

Essenvia drives business value and brings cross-functional efficiency gains to all teams and departments. Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs, and RFIs. Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals. Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global registrations, submissions, and change assessment. Essenvia is a RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Consolidate your regulatory activities into one centralized platform and bring your devices to market faster. Central repository for all registration docs linked to product master data. Manage product registration lifecycle by country.

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.

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

Medtech companies in need of a solution to manage their regulatory workflows across the total product lifecycle

Audience

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

Support

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

Support

Phone Support 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

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial 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:

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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 Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Not Supported
In Person Supported

Company Information

Essenvia
United States
essenvia.com

Company Information

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

Alternatives

Alternatives

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ProcEdge RIMS

Sarjen Systems Pvt Ltd
LICENSALE

LICENSALE

Arazy Group
MedAffairs AI

MedAffairs AI

Accreditation Council for Medical Affairs (ACMA)
Rimsys

Rimsys

Rimsys Regulatory Management Software
LICENSALE

LICENSALE

Arazy Group

Categories

Categories

Medical Affairs Supported

Integrations

Arena PLM Supported
EQMS Supported
Oracle Fusion Cloud PLM Supported
Qualio Supported

Integrations

Arena PLM Not Supported
EQMS Not Supported
Oracle Fusion Cloud PLM Not Supported
Qualio Not Supported
Claim Essenvia and update features and information
Claim Essenvia and update features and information
Claim RAMS and update features and information
Claim RAMS and update features and information