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Description
Regulatory responsibilities rely heavily on expensive contributors within various regulatory materials. A cloud-based solution such as the Infosys regulated document management platform effectively addresses these challenges. It allows for externalization and collaborative authoring and editing of documents, thus simplifying governance and processes while implementing a consumption-based commercial model that includes support for audit trails. Additionally, it facilitates the creation of custom workflows and offers assistance with versioning, all backed by a proven solution that guarantees 99.95% uptime in production environments. This innovative system enables business users to swiftly locate documents from an extensive repository in just three to four seconds. Furthermore, users benefit from unlimited on-demand storage, enhancing their ability to manage data efficiently. The DMS leverages Google application programming interfaces (APIs) to minimize operational and maintenance expenses, ensuring that the company's overhead costs are confined to API usage and storage requirements. By adopting this advanced platform, organizations can significantly improve their regulatory compliance processes while also cutting costs.
Description
Introducing a comprehensive global regulatory affairs platform, featuring registration management tools and expert support from regulatory professionals worldwide. This system is essential for initiating, renewing, modifying, or transferring market access approvals for your medical devices or IVDs. With LICENSALE®'s user-friendly interface and real-time data capabilities, you gain access to complete project management tools, infographic analytics, a seamless collaboration space, future market access strategies, and detailed reporting features. This empowers you to oversee your global medtech registration processes effectively. Regulatory specialists from Arazy Group meticulously examine your compliance documents, providing guidance in the preparation and submission of your applications, and they liaise with authorities until you secure the necessary marketing approvals. Furthermore, LICENSALE® encompasses specific submission and compliance requirements tailored to your product across over 140 countries, with dedicated regulatory experts available to assist in navigating each market's unique challenges. By leveraging this system, you can streamline your regulatory processes and enhance your overall market entry strategy.
API Access
Has API
API Access
Has API
Integrations
Axe Credit Portal
Work-Relay
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
Infosys
Founded
1981
Country
India
Website
www.infosys.com/industries/life-sciences/industry-offerings/regulated-document-management-platform.html
Vendor Details
Company Name
Arazy Group
Country
Canada
Website
arazygroup.com/licensale-2/