Compliance Tracking

AI continuously monitors and adapts to evolving local and global regulatory standards, automatically updating processes to ensure compliance without manual intervention.

Predictive Analytics

Leveraging AI, the solution analyzes historical and real-time data to identify potential risks and compliance gaps before they escalate.

Reporting & Documentation

Automates generation of regulatory reports and documentation, ensuring accuracy, timeliness, and audit readiness with minimal human involvement.

Risk Mitigation

AI-powered algorithms assess data patterns to flag potential compliance risks and recommend corrective actions before issues arise.

Regulatory Change Management

Tracks regulatory changes in real time and automatically implements them to ensure ongoing compliance with the latest standards.

Enhanced Efficiency

Optimizes workflows, reduces operational costs, accelerates regulatory processes, and ensures consistent compliance across the organization.

Tracking and Publishing of Submissions

Monitor, track, and publish regulatory submissions efficiently within the system.

Reviewing Submissions

Dedicated functionality for systematic review of submissions before finalization to ensure compliance.

Approval and Rejection Monitoring

Real-time tracking of approval or rejection status for each submission to streamline decision-making.

FDA Target Date Notifications

Notifications for FDA target dates to ensure timely compliance with critical regulatory deadlines.

Product Registration

Collect and manage product registration information seamlessly within the system.

Superb Authentication

Validate records using e-signatures, timestamps, and role-based access for enhanced security.

Submission Validation

Ensures compliance and technical accuracy of documents prior to regulatory submissions.

Automatic Notifications for Critical Dates

Receive timely alerts for FDA target dates and other compliance milestones.

Cost Reduction

Reduce operational expenses while improving productivity and efficiency.

Submission Preparation & Management

Create, track, review, and publish submissions easily with real-time approval monitoring.

Change Control Management

Tracks and regulates changes to regulatory documents, ensuring full traceability throughout the lifecycle.

Graphical Reports

Interactive graphical reports for easier analysis and informed decision-making.

Real-time Notifications

Receive instant email notifications for regulatory commitments and updates.

Product Registration Tracking

Easily collect and update product registration data for accurate regulatory reporting.

Centralized Database

Access a centralized database from anywhere for streamlined information retrieval.

Vendor Management

Manage and coordinate third-party vendors to ensure regulatory compliance.

Product Lifecycle Management

Manages product development lifecycle from regulatory approval to market release.

Cross-Industry Compatibility

Applicable across industries including life sciences, food & beverages, and cosmetics.

Workflow Automation

Automates repetitive regulatory processes to reduce turnaround time and compliance risks.

Audit Trials

Maintains audit trails of system modifications to support accountability and forensic audits.