Average Ratings 19 Ratings
Average Ratings 0 Ratings
Description
RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies.
• 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.
Description
RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.
API Access
Has API
No
API Access
Has API
No
Integrations
Active Directory
Yes
Arena
Yes
Asana
Yes
Boomi
Yes
Dynamics 365 Customer Service
Yes
Jira
Yes
Montrium Connect
No
MuleSoft Anypoint Platform
Yes
Okta
Yes
OpenText AI Operations Management
Yes
Integrations
Active Directory
No
Arena
No
Asana
No
Boomi
No
Dynamics 365 Customer Service
No
Jira
No
Montrium Connect
Yes
MuleSoft Anypoint Platform
No
Okta
No
OpenText AI Operations Management
No
Pricing Details
Contact us to learn more.
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
No
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)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
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
RegDesk
Founded
2014
Country
United States
Website
www.regdesk.co
Vendor Details
Company Name
Montrium
Country
Canada
Website
www.montrium.com
Product Features
Product Features
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
Yes
Document Assembly
Yes
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
Yes
Electronic Signature
Yes
Email Management
No
File Recovery
Yes
File Type Conversion
Yes
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
Yes