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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

Emergo by UL's Regulatory Affairs Management Suite (RAMS) is an all-encompassing software-as-a-service solution crafted to optimize regulatory and quality management processes for companies involved in medical devices and in vitro diagnostics. Drawing on extensive expertise in regulatory compliance, RAMS equips users with a range of tools to effectively navigate the intricate and ever-changing realm of global medical device regulations. Among its standout features is product classification, which assists users by guiding them through a structured series of inquiries to ascertain or confirm the classification of their devices. Additionally, the Smart Builder offers comprehensive step-by-step instructions and ready-made text to aid in the creation of precise regulatory documentation, thereby facilitating a smoother path to device registration and expedited market entry. Furthermore, the Registration Tracker serves to automate the oversight of international registrations and certifications, ensuring that organizations do not overlook renewals and consistently uphold compliance standards. This proactive approach not only enhances efficiency but also significantly reduces the risk of regulatory setbacks.

Description

The Vault RIM Suite offers a comprehensive platform for managing regulatory information from end to end. By centralizing global regulatory workflows on a cloud-based system, it enhances visibility, data quality, and responsiveness for life sciences organizations. This allows companies to adapt swiftly to shifting regulations while improving efficiency throughout the submission process, from planning to final publication. The platform facilitates collaboration among headquarters, affiliates, and partners, all within a unified RIM system. Furthermore, it guarantees that teams produce regulatory content that is both reliable and maintains high data integrity. Veeva Vault Registrations oversees product registration details on a global scale, covering registration status, variations, and interactions with health authorities. Its adaptable data model is designed to incorporate IDMP data points and will keep pace with changing regulatory data standards. Additionally, Veeva Vault Submissions optimizes the submission planning process by automating various steps in the regulatory workflow, leading to significant time savings and improved outcomes. This unified approach ultimately empowers companies to navigate the complexities of regulatory compliance with greater ease and precision.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

5X No 
Freu AI No 
Indent No 

Integrations

5X Yes 
Freu AI Yes 
Indent Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
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) No 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Emergo by UL

Country

United States

Website

www.emergobyul.com/software/regulatory-affairs-management-suite

Vendor Details

Company Name

Veeva

Country

United States

Website

www.veeva.com/products/vault-rim/

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