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Description
Kalypso offers a budget-friendly solution for life sciences organizations looking to implement a Regulatory Information Management (RIM) system, known as Accel for RIM. This platform facilitates an integrated approach to effectively oversee and monitor product registrations while enhancing the accuracy of submissions and managing global Unique Device Identification (UDI) information, thereby streamlining product distribution. It also merges compliance and quality data from multiple enterprise systems into a comprehensive source of truth for product registrations and tracking, which expedites regulatory submissions. Utilizing modern APIs, it aggregates product data along with necessary regulatory documentation and submission packages. The system is pre-configured for swift deployment and is built on a validated software framework, grounded in the best practices and successful implementations within the industry. By adopting this solution, companies can expect not only efficiency but also a significant reduction in time spent on regulatory tasks.
Description
Emergo by UL's Regulatory Affairs Management Suite (RAMS) is an all-encompassing software-as-a-service solution crafted to optimize regulatory and quality management processes for companies involved in medical devices and in vitro diagnostics. Drawing on extensive expertise in regulatory compliance, RAMS equips users with a range of tools to effectively navigate the intricate and ever-changing realm of global medical device regulations. Among its standout features is product classification, which assists users by guiding them through a structured series of inquiries to ascertain or confirm the classification of their devices. Additionally, the Smart Builder offers comprehensive step-by-step instructions and ready-made text to aid in the creation of precise regulatory documentation, thereby facilitating a smoother path to device registration and expedited market entry. Furthermore, the Registration Tracker serves to automate the oversight of international registrations and certifications, ensuring that organizations do not overlook renewals and consistently uphold compliance standards. This proactive approach not only enhances efficiency but also significantly reduces the risk of regulatory setbacks.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
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
Kalypso
Founded
2004
Country
United States
Website
kalypso.com/industries/life-sciences/digital-regulatory-information-management/
Vendor Details
Company Name
Emergo by UL
Country
United States
Website
www.emergobyul.com/software/regulatory-affairs-management-suite