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features
design
support

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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 No 

API Access

Has API No 

Screenshots View All

No images available

Screenshots View All

No images available

Integrations

AmpleLogic LCNC Platform Yes 

Integrations

AmpleLogic LCNC Platform No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$300
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac Yes 
Linux Yes 
Chromebook Yes 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
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) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
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

AmpleLogic

Founded

2010

Country

India

Website

amplelogic.com

Vendor Details

Company Name

Sarjen Systems Pvt Ltd

Founded

1998

Country

India

Website

rims.sarjen.com

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