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What is Regislate?

Acquire all essential tools to successfully register your medical device or IVD product in international markets while managing your market access license throughout its entire life cycle. REGISLATE® provides users with detailed submission file requirements customized for distinct medical and IVD device specifications in various countries. This platform allows you to track milestones, timelines, and both estimated and actual completion dates for initial registrations, renewals, amendments, and license transfers in real-time. In addition, it presents infographic data and unique indicators to support clear oversight and management of each project. Utilize collaborative features that aid in the preparation and evaluation of submissions, ensuring adherence to all critical requirements and documentation. Stay updated with real-time reports on both ongoing and future submissions, complete with insights into market access preparedness. Furthermore, REGISLATE® includes GR-MAP registration tracking, which offers comprehensive visibility regarding both the country and product involved. This integrated strategy guarantees that users are thoroughly prepared to skillfully navigate the intricate landscape of market access, ultimately enhancing efficiency and compliance throughout the process. Regular updates and user-friendly navigation further enrich the experience, making it an invaluable resource for professionals in the industry.

What is DXC RIM?

The DXC RIM platform acts as a unified center for handling regulatory affairs content, data, and workflows, empowering teams to boost their innovation capabilities and reduce their market entry timelines. Given the pivotal role of regulatory affairs (RA) content, an integrated platform is crucial for the effective management of both regulatory data and workflows. Teams need prompt and easy access to all relevant information to operate at their best. Furthermore, a customizable and user-friendly interface is essential to ensure smooth navigation through the system. Achieving success also hinges on the availability of collaborative tools and flexible reporting options, as outdated technology can impede progress and extend timelines. Navigating compliance can present significant hurdles, as gathering data and documenting procedures often requires substantial time and resources. This challenge is exacerbated for life sciences organizations that rely on fragmented legacy systems utilizing diverse technologies. In many cases, they may find themselves resorting to spreadsheets to handle vital operational responsibilities. Therefore, to successfully launch products and manage regulatory affairs, organizations must adopt a strong, centralized solution. This comprehensive strategy not only optimizes workflows but also cultivates a setting that supports both compliance and innovation, ultimately leading to improved outcomes for teams and the organization as a whole. The importance of such a platform cannot be overstated, as it facilitates a more agile response to regulatory changes and market demands.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Arazy Group

Company Location

Canada

Company Website

arazygroup.com/regislate-software/

Company Facts

Organization Name

DXC

Company Location

United States

Company Website

dxc.com/content/dam/dxc/projects/dxc-com/us/pdfs/services/applications/DG_8702a-23%20RIM%20Platform%20Offering%20Overview_v9.pdf

Categories and Features

Categories and Features

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