Regulatory Information Management System (RIMS)

AmpleLogic’s Regulatory Information Management System (RIMS) is an AI-powered platform designed to centralize and automate regulatory workflows across industries such as pharmaceuticals, medical devices, CDMOs, CROs, chemicals, and food & beverages. It simplifies complex regulatory processes, reduces manual effort, and ensures compliance with global standards like 21 CFR Part 11 and EU Annex 11. The system supports product registration, submission tracking, change control, and lifecycle documentation, helping organizations stay audit-ready and efficient.

Features

• Automated regulatory submission tracking
• Product registration and lifecycle management
• Change control and variation management
• FDA target date notifications and alerts
• Submission validation and approval monitoring
• Role-based access and electronic authentication
• Graphical reporting and analytics
• Centralized database with remote access
• Vendor management and commitment tracking

Capabilities

• Streamlines regulatory submissions from creation to approval
• Tracks commitments, variations, and regulatory obligations
• Automates reminders for critical compliance dates
• Validates documents for technical accuracy before submission
• Enables real-time monitoring of approval and rejection status
• Supports cross-functional collaboration and data integrity
• Manages ANDA and DMF lifecycles with dedicated trackers
• Adapts to evolving regulatory landscapes and business growth

Benefits

• Reduces compliance risks and operational costs
• Enhances submission accuracy and timeliness
• Improves audit readiness and documentation traceability
• Minimizes manual errors and delays
• Boosts productivity through workflow automation
• Enables faster approvals and market access
• Strengthens regulatory oversight and decision-making
• Scales with organizational needs and regulatory complexity