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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 RIMExpert?

RIMExpert™ significantly optimizes regulatory planning, tracking, and data management by managing global rollout strategies and automating the preparation of regulatory submissions, activities, and medicinal products. By reducing the need for extensive data entry, RIMExpert™ improves data integrity and increases global oversight and control. The platform standardizes processes involved in regulatory planning, tracking, and registration management, which enhances collaboration between headquarters and their affiliates. It creates a centralized hub for all activities related to registrations, allowing for a single access point that gathers inquiries, commitments, correspondence, and authorizations for each application, thus aligning efforts to maximize efficiency in regulatory resources across the enterprise. Moreover, RIMExpert™ provides meticulous oversight of registration activities throughout the entire product lifecycle, ensuring that timelines, commitments, and agency inquiries are consistently monitored. It includes interactive dashboards that deliver a holistic view of regulatory actions and registrations, equipping teams with the insights needed for informed decision-making and prompt responses. By doing so, RIMExpert™ not only fortifies regulatory compliance but also enhances the overall effectiveness of the organization, paving the way for improved operational success. This comprehensive approach ultimately strengthens the framework within which regulatory processes are managed and executed.

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

AMPLEXOR

Date Founded

1987

Company Location

Luxembourg

Company Website

www.amplexor.com/en/life-sciences-suite/rim/regulatory-planning-tracking.html

Categories and Features

Categories and Features

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