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What is Vistaar by DDi?

Vistaar stands out as a cutting-edge cloud-based platform tailored to meet the regulatory intelligence and compliance demands of businesses in the pharmaceutical, biotechnology, medical device, diagnostics, and consumer health industries. It features a vast and searchable collection of regulatory documents and requirements, while also monitoring changes in over 150 countries, providing timely notifications and in-depth summaries of any updates. Users can delve into regulations, guidance, and standards, assess their impacts on products and operations, assign tasks, and track obligations, deadlines, and evidence through organized workflows and compliance matrices. With the integration of AI capabilities, the platform enhances the regulatory review process with sophisticated search options, document summaries, translation services, and obligation extractions. Human-reviewed summaries are meticulously curated to ensure that users receive the most pertinent requirements for their specific needs. Furthermore, Vistaar incorporates functionalities for reporting, maintaining audit trails, and seamlessly integrating with existing electronic document management systems, regulatory information management tools, and quality management systems. This platform is expertly crafted to assist regulatory affairs, quality assurance, and compliance teams as they maneuver through the complex landscape of global life sciences regulations, proving itself to be an indispensable asset. By optimizing compliance processes, Vistaar not only streamlines operations but also allows organizations to concentrate on innovation and enhancing patient outcomes, ultimately fostering a healthier future.

What is RAMS?

The Regulatory Affairs Management Suite (RAMS) by Emergo, a UL company, provides a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for businesses in the medical device and in vitro diagnostics sectors. Leveraging deep regulatory compliance knowledge, RAMS offers an array of tools that enable users to adeptly maneuver through the complex and evolving landscape of global medical device regulations. A notable feature includes product classification, which helps users by leading them through a systematic series of questions to determine or verify their device classifications accurately. The Smart Builder feature provides detailed, step-by-step guidance along with pre-written text to assist in the development of precise regulatory documents, making the process of device registration more efficient and accelerating market access. Additionally, the Registration Tracker automates the management of international certifications and registrations, helping organizations to stay on top of renewals and maintain compliance consistently. By adopting this proactive methodology, companies not only improve their operational efficiency but also effectively mitigate the likelihood of regulatory challenges, allowing them to focus on innovation and growth in the competitive medical device market. Ultimately, RAMS empowers businesses to navigate regulatory landscapes with confidence and agility.

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Integrations Supported

ViSU

Integrations Supported

API Availability

Has API

API Availability

Pricing Information

Free Quick Access provides limited navigation and data-availability checks for one or two countries. The free proof-of-concept pilot provides 7 days of unlimited cloud use with full data for selected countries.
Free Trial Offered?

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Webinars
On-Site Training

Company Facts

Organization Name

DDismart

Date Founded

2015

Company Location

United States

Company Website

www.vistaar.ai/

Company Facts

Organization Name

Emergo by UL

Company Location

United States

Company Website

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

Categories and Features

Categories and Features

Medical Affairs

Not specified

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