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Description
The AmpleLogic Regulatory Information Tracker is designed using a LOW CODE AND NO CODE (LCNC) PLATFORM and features two primary modules: the ANDA Tracker and the DMF Tracker. This innovative Pharmaceutical RIMS Software enhances data quality, increases operational efficiency, reduces errors, and facilitates smoother communication between various departments, ultimately contributing to a more effective regulatory management process. By implementing this tool, organizations can achieve a higher level of compliance and stay ahead in the competitive pharmaceutical landscape.
Description
ProcEdge Regulatory Information Management System (RIMS) provides companies with a powerful, centralized platform to manage complex regulatory requirements for their entire global product portfolio. Moving away from traditional Excel-based tracking, it offers a single source of truth that connects multiple departments, providing 360-degree visibility and real-time updates on product registration, license maintenance, and post-registration activities. The platform enables detailed planning and tracking of submission timelines tailored to country-specific regulations, helping users meet compliance standards and reduce costly errors. It features configurable data models, automated email notifications, and a robust workflow engine that streamlines query management and response tracking. ProcEdge RIMS complies with global standards like IDMP and regulatory frameworks including GxP, GDPR, and Part 11. By eliminating redundant systems and manual data entry, it significantly reduces operational expenses and accelerates health agency approvals. The system’s audit trails and electronic signature capabilities ensure data integrity and regulatory reliability. Overall, it empowers regulatory professionals to make faster, informed decisions and maintain product marketability efficiently.
API Access
Has API
API Access
Has API
Screenshots View All
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Screenshots View All
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Integrations
AmpleLogic LCNC Platform
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$300
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
AmpleLogic
Founded
2010
Country
India
Website
amplelogic.com
Vendor Details
Company Name
Sarjen Systems Pvt Ltd
Founded
1998
Country
India
Website
rims.sarjen.com