Regislate Description
All the information you need to register your IVD product or medical device in any market worldwide and manage your market access licence throughout the product's life cycle. REGISLATE®, which provides information about medical and IVD device-specific submission file requirements for each country, allows users to manage their market access licenses through the product life cycle. You can track milestones, timelines, estimated and actual completion dates, as well as estimated and actual completion dates, for initial registrations, renewals, amends, and license transfers, in real-time. For clear monitoring and management, infographic data and proprietary indicators are available. Collaboration tools are available to assist with the preparation and review submissions, compliance requirements, and documents. Receive progress reports in real time for current and future submissions, including market access readiness index. REGISLATE®, which includes GR-MAP registration tracking, for both country AND product.
Regislate Alternatives
Essenvia
Essenvia delivers business value to all departments and teams, and increases efficiency across the board. Centralized repository of all regulatory information allowing collaborative authoring, reporting, and eliminating technical holds, RTAs and RFIs. The regulatory affairs department is empowered to accelerate product launches, and eliminate revenue losses due to delays in submissions and missed renewals. Helicopter view over the entire regulatory lifecycle. Executive dashboards, metrics and proactive alerts are available for global registrations and submissions. Essenvia, a RIM Platform, allows you to manage regulatory workflows throughout the entire product lifecycle. It also accelerates global market access and generates exponential business value. Consolidate all regulatory activities onto one platform to bring your devices faster to market. All registration documents linked to product master information are stored in a central repository. Manage the product registration lifecycle per country.
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MasterControl
It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation.
Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge.
Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.
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Samarind RMS
Samarind RMS is a smarter way for you to manage your medical product information. Samarind RMS allows you to only enter data once, and you can reuse it as often as necessary. An example of this is the 'INN' which can be used once and reused for all IMA submissions, renewals and variations. This concept is applicable to all key data within the system. It has been proven to improve data quality and streamline workflows. Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system. An electronic document management system (EDMS), which includes version control, template creation, and the ability to link with external document management systems like Documentum™, SharePoint™.
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LICENSALE
Global regulatory affairs system that includes registration management software and support from regulatory experts around the world. This registration system is required to renew, amend, transfer, or modify your IVD market access approval or medical device. The intuitive user interface of LICENSALE®, which includes real-time data and infographic analytics, allows for project management, collaboration, future market access planning, advanced reporting, and effective project management. It allows you to take control of your global medical technology registration activities. Arazy Group's "in-country regulatory experts" review your compliance documents and assist in the preparation of your applications. They will work with authorities until you receive your desired marketing approvals. LICENSALE®, which includes compliance and submission requirements for your product in over 140 countries, as well as regulatory experts to help you with each market.
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Company Details
Company:
Arazy Group
Headquarters:
Canada
Website:
arazygroup.com/regislate-software/
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Product Details
Platforms
SaaS
Type of Training
Documentation
Live Online
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Online
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