Ratings and Reviews 16 Ratings
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What is RegDesk?
RegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies.
• Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates.
• With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time.
• The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions.
• Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners.
• The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards.
• Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators.
To learn more about our offerings, please explore our website.
What is Ennov Regulatory Suite?
The Ennov Regulatory Suite stands out as a premier solution for managing regulatory content and information. This comprehensive, centralized platform facilitates the entire regulatory information workflow, spanning from initial stages to market authorization. Companies aiming for excellence in regulatory operations commonly adopt this approach because it fosters harmonization and promotes standardization, enhances collaboration while ensuring compliance, reduces waste and costs, accelerates time-to-market, and enables them to effectively compete in the global arena. The suite includes Ennov Doc, Ennov Dossier, and Ennov Process, which collectively support the complete regulatory product lifecycle, from the early phases of setting registration goals to the eventual retirement of products. By utilizing the Ennov Regulatory Suite, organizations can strategically plan their regulatory activities and streamline their processes efficiently. This makes it an indispensable asset for companies navigating the complexities of regulatory compliance.
Integrations Supported
Ennov RIM
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
RegDesk
Date Founded
2014
Company Location
United States
Company Website
www.regdesk.co
Company Facts
Organization Name
Ennov
Date Founded
1999
Company Location
France
Company Website
en.ennov.com
Categories and Features
Categories and Features
Compliance
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
