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features
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Description

Gain all the necessary resources to effectively register your medical device or IVD product in global markets while overseeing your market access license throughout the product's life cycle. REGISLATE® equips users with comprehensive submission file requirements tailored to specific medical and IVD device needs for each country. With this platform, you can monitor milestones, timelines, as well as estimated and actual completion dates for initial registrations, renewals, amendments, and license transfers as they happen. Additionally, it offers infographic data and exclusive indicators to facilitate transparent oversight and management of every project. Take advantage of collaboration tools that assist in the preparation and review of submissions, ensuring compliance with all necessary requirements and documentation. Stay informed with real-time progress reports on both current and upcoming submissions, including insights into market access readiness. Furthermore, REGISLATE® features GR-MAP registration tracking, providing comprehensive oversight for both the country and product involved. This holistic approach ensures that users are well-equipped to navigate the complexities of market access efficiently.

Description

eProtocol serves as a comprehensive online platform dedicated to research compliance for various institutions overseeing human subjects, animals, biosafety, and other regulated studies. This system facilitates the development and electronic submission of protocols, as well as the workflows for committee review and approval, amendments, renewals, reporting of adverse events, automated routing and reminders, version control, meeting agendas and minutes, audit trails, and comprehensive reporting. Users such as investigators, coordinators, reviewers, and compliance administrators can efficiently monitor protocol statuses and access relevant records through a collaborative interface. The platform features specific modules tailored for IRB, IACUC, IBC, stem-cell research, chemical safety, radiation safety, controlled substances, and post-approval monitoring processes. eProtocol is specifically crafted to meet the needs of universities, research institutions, hospitals, academic medical centers, biotech and pharmaceutical companies, as well as governmental research agencies, ensuring a streamlined approach to compliance across diverse research environments. Additionally, it enhances the overall efficiency of regulatory processes, ultimately contributing to the integrity and safety of research activities.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
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 Yes 
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 No 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

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

Vendor Details

Company Name

Arazy Group

Country

Canada

Website

arazygroup.com/regislate-software/

Vendor Details

Company Name

Key Solutions

Founded

1991

Country

United States

Website

www.keyusa.com

Product Features

Alternatives

Alternatives

No Alternatives
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