Ennov RIM Description
Imagine all your regulatory information about products, registrations and submissions, correspondence, and commitments in one central place, accessible from anywhere. Ennov RIM allows life sciences companies to streamline their regulatory processes, improve data quality, quickly respond to business-critical questions, and effectively responds to health authority requests. Ennov RIM, a purpose-built application based on Ennov Process, allows for the tracking and management of therapeutic product details as well as registration information. Ennov RIM gives regulatory personnel the essential information and functionality they need to manage product portfolios globally, whether you're planning to launch a new product or handle variations to existing registrations.
Ennov RIM Alternatives
Veeva Vault RIM
End-to-end regulatory information management from a single platform. The Vault RIM Suite streamlines global regulatory process on a single cloud-based platform. This allows life sciences companies to increase visibility, data quality, agility, and efficiency. You can respond faster to changes in regulations and improve process efficiency, from submission planning to publication. Coordinate regulatory efforts across HQ and affiliates within a single RIM platform. Assure that teams are creating reliable regulatory content with high data integrity. Veeva Vault Registrations manages product data worldwide, including variations, registration status, and interactions with health authorities. Veeva's flexible data structure supports IDMP data points, and will continue to support changing regulatory data standards. Veeva Vault Submissions automates regulatory process steps and streamlines submission planning.
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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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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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Ennov Regulatory Suite
Ennov Regulatory Suite is a world-class solution for regulatory content and information management. It is a unified, centralized and end-to-end solution that supports the regulatory information workflow, from the earliest stages through market authorization. This is a common principle that companies who strive to achieve regulatory operational excellence share. This is because they know that such a solution will allow them to drive harmonization and promote standardization, improve collaboration and ensure compliance, eliminate waste and reduce costs, accelerate product releases, and allow them operate and compete in global markets more effectively. Ennov Doc, Ennov Dossier, and Ennov Process combine to provide support for the entire regulatory product cycle, from early planning of registration targets to product retirement. The Ennov Regulatory Suite is a valuable tool for planning regulatory activity.
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Integrations
Company Details
Company:
Ennov
Year Founded:
1999
Headquarters:
France
Website:
en.ennov.com/regulatory-content-information-management/rim-regulatory-information-management/
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Product Details
Platforms
SaaS
Type of Training
Documentation
Customer Support
Phone Support
Online
Ennov RIM Features and Options
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