Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
Essenvia enhances business value and improves operational efficiency across various teams and departments. It serves as a centralized hub for all regulatory data, facilitating collaborative document creation and reporting while helping to prevent technical holds, RTAs, and RFIs. This platform empowers the regulatory affairs team to speed up product launches, thus avoiding revenue losses associated with submission delays and missed renewals. It provides a comprehensive overview of the entire regulatory lifecycle, complete with executive dashboards, key performance indicators, and proactive alerts for global registrations, submissions, and change assessments. Essenvia acts as a Regulatory Information Management (RIM) Platform that streamlines regulatory workflows throughout the entire product lifecycle, enabling faster global market access and delivering significant business advantages. By consolidating all regulatory activities into one unified platform, businesses can accelerate their market entry. Additionally, it includes a central repository for all registration documents, which are linked to product master data, allowing users to effectively manage the product registration lifecycle on a country-by-country basis while ensuring compliance and efficiency.
API Access
Has API
No
API Access
Has API
No
Integrations
Arena PLM
No
EQMS
No
Ennov RIM
Yes
Oracle Fusion Cloud PLM
No
Qualio
No
Integrations
Arena PLM
Yes
EQMS
Yes
Ennov RIM
No
Oracle Fusion Cloud PLM
Yes
Qualio
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Ennov
Founded
1999
Country
France
Website
en.ennov.com
Vendor Details
Company Name
Essenvia
Country
United States
Website
essenvia.com
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
No
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes