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Description
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.
Description
ViSU™ is an innovative cloud-based platform for End-to-End Regulatory Information Management (RIM) tailored for the medical device sector, allowing users worldwide to efficiently access and oversee essential Regulatory Data, including Product Master details, Registrations, and Tracking. This comprehensive tool also facilitates the management of Dossiers and Technical Files through submission planning, development, and lifecycle management, while streamlining communication with Health Authorities and Notified Bodies, tracking obligations, managing Unique Device Identification (UDI), electronic Instructions for Use (eIFU), maintaining a Regulatory Requirements Database, and controlling changes. By adopting ViSU, organizations can fully harness the power of digital transformation in regulatory processes, achieving improved connectivity, enhanced traceability, and significant automation. Ultimately, ViSU contributes to heightened regulatory management efficiency, reduced compliance risks, and lowered operational costs, making it an indispensable asset for the industry. Moreover, its user-friendly interface ensures that teams can navigate the complexities of regulatory requirements with ease.
API Access
Has API
API Access
Has API
Integrations
Ennov Regulatory Suite
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
Ennov
Founded
1999
Country
France
Website
en.ennov.com/regulatory-content-information-management/rim-regulatory-information-management/
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com