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ease
features
design
support

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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

Safeguard your enterprise and adhere to country-specific drug serialization mandates and rapidly evolving regulations while effectively managing vast data quantities with smart solutions. Utilize the SAP Advanced Track and Trace for Pharmaceuticals application to ensure compliance with both international and local laws, as it features a comprehensive serialization repository, efficient serial number management, and robust regulatory reporting functions. Lower the costs associated with compliance for both current and future serialization obligations, including specific reporting requirements for various nations. Enhance your supply chain's productivity by gaining deeper insights into the movement of materials, all the way down to the sales-unit-item level. Efficiently manage extensive serialization data while staying agile enough to embrace new legislative changes. Maintain oversight of retail product serial numbers within a centralized corporate repository, ensuring that you meet all country-specific regulations when it comes to reporting these serial numbers. By implementing these strategies, your business can not only streamline operations but also stay ahead in a competitive market.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Nextbitt
SAP Joule
Streams.AI by PanTerra Networks
TrueCommerce

Integrations

Nextbitt
SAP Joule
Streams.AI by PanTerra Networks
TrueCommerce

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Arazy Group

Country

Canada

Website

arazygroup.com/regislate-software/

Vendor Details

Company Name

SAP

Founded

1972

Country

Germany

Website

www.sap.com/products/track-trace-pharmaceuticals.html

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