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Ratings and Reviews 0 Ratings
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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 Kalypso Accel for RIM?
Kalypso provides an economical option for life sciences companies aiming to adopt a Regulatory Information Management (RIM) system called Accel for RIM. This innovative platform supports a cohesive strategy for efficiently managing and overseeing product registrations, while also improving submission accuracy and handling global Unique Device Identification (UDI) details, which helps in optimizing product distribution. Furthermore, it integrates compliance and quality data from various enterprise systems into a single, reliable source for tracking product registrations, thus speeding up the regulatory submission process. By leveraging modern APIs, the system compiles product information along with essential regulatory documents and submission packages. Designed for quick implementation, it is based on a validated software framework that incorporates industry best practices and proven successful deployments. Companies that implement this solution can anticipate not only increased operational efficiency but also a notable decrease in the time required for regulatory activities. Additionally, this streamlined approach can significantly enhance organizational productivity and focus on strategic initiatives.
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
Kalypso
Date Founded
2004
Company Location
United States
Company Website
kalypso.com/industries/life-sciences/digital-regulatory-information-management/