Ennov Regulatory Suite Description
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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RegDesk
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• Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes
• Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time
• Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required
• Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners
• Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards
• Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds
For more information, visit our website.
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Ennov RIM
Envision having all your regulatory details related to products, registrations, submissions, correspondence, and commitments consolidated in a single, easily accessible location. With Ennov RIM, companies in the life sciences sector can enhance their regulatory workflows, elevate data integrity, swiftly address crucial business inquiries, and efficiently fulfill requests from health authorities. Specifically designed for the oversight and monitoring of therapeutic product information and registration data, Ennov RIM is rooted in Ennov Process. Regardless of whether you are preparing for the introduction of a new product or managing adjustments to current registrations, Ennov RIM equips regulatory teams with essential information and tools to proficiently oversee product portfolios on a global scale. This comprehensive approach not only fosters compliance but also promotes strategic decision-making across the organization.
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Integrations
Company Details
Company:
Ennov
Year Founded:
1999
Headquarters:
France
Website:
en.ennov.com
Media
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Product Details
Platforms
Web-Based
Windows
Types of Training
Live Training (Online)
In Person
Customer Support
Business Hours
Live Rep (24/7)
Ennov Regulatory Suite Features and Options
Compliance Software
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Ennov Regulatory Suite User Reviews
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