ProcEdge RIMSSarjen Systems Pvt Ltd
|
cubeSAFETYCRScube
|
|||||
Related Products
|
||||||
About
ProcEdge RIMS is a centralized regulatory information management system designed to streamline global product registration and post-registration activities. It replaces error-prone manual methods like Excel with a unified platform that offers real-time access to product data across departments. The system tracks submissions, renewals, and regulatory correspondence with configurable workflows and automated reminders to ensure compliance with varying international regulations. It supports industry standards such as IDMP and meets GxP, GDPR, and 21 CFR Part 11 compliance requirements. By consolidating regulatory data and workflows, ProcEdge RIMS helps companies reduce operational costs and speed up time to market. Its robust query management and audit trail features improve submission quality and regulatory responsiveness.
|
About
cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead.
|
|||||
Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
|
Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
|
|||||
Audience
Regulatory affairs professionals and compliance teams in pharmaceutical, biotech, and healthcare industries seeking a centralized, compliant platform to manage global product registration and regulatory information efficiently
|
Audience
Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management
|
|||||
Support
Phone Support
24/7 Live Support
Online
|
Support
Phone Support
24/7 Live Support
Online
|
|||||
API
Offers API
|
API
Offers API
|
|||||
Screenshots and VideosNo images available
|
Screenshots and Videos |
|||||
Pricing
$300
Free Version
Free Trial
|
Pricing
No information available.
Free Version
Free Trial
|
|||||
Reviews/
|
Reviews/
|
|||||
Training
Documentation
Webinars
Live Online
In Person
|
Training
Documentation
Webinars
Live Online
In Person
|
|||||
Company InformationSarjen Systems Pvt Ltd
Founded: 1998
India
rims.sarjen.com
|
Company InformationCRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety
|
|||||
Alternatives |
Alternatives |
|||||
|
|
||||||
|
|
||||||
|
|
|
|||||
|
|
|
|||||
Categories |
Categories |
|||||
Integrations
XML
cubeCDMS
cubeCTMS
|
||||||
|
|
|