iRIMS - Intergrated Regulatory
Information Management System
Complete end-to-end iRIMS solution with 28 integrated modules, Al-powered validation, WHO GBT compliance, and Web3 technology. Serving regulatory authorities across Africa since 2012.
28 Comprehensive Modules
Complete pharmaceutical regulatory management suite covering all aspects of drug regulation and compliance
Product Registration
Streamline pharmaceutical approvals with automated workflows, reducing registration time by 60% while ensuring full regulatory compliance and documentation tracking
Premise Inspections and Licensing
Transform facility inspections with smart scheduling, digital checklists, and instant report generation – eliminating paperwork and accelerating licensing decisions
GMP Inspection and Registration
Ensure Good Manufacturing Practice compliance with AI-powered assessment tools, automated scoring, and real-time certification status tracking
Import and Export Management
Accelerate international trade with digital permit processing, automated customs integration, and real-time shipment tracking across borders
Post Marketing Surveillance
Protect public health with continuous drug safety monitoring, automated adverse event detection, and predictive risk assessment algorithms
Promotion and Advertisement Management
Control pharmaceutical marketing with intelligent content screening, automated compliance checking, and real-time advertisement monitoring
Clinical Trial Management
Accelerate medical research with end-to-end trial oversight, participant tracking, and automated regulatory reporting for faster drug development
Disposal Management
Ensure environmental safety with comprehensive pharmaceutical waste tracking, automated disposal scheduling, and full chain-of-custody documentation
Reporting (ADR, AEFIs, SAEs)
Enhance patient safety with intelligent adverse event reporting, automated signal detection, and seamless integration with global pharmacovigilance networks
PSUR & PBRER & Line Listing
Automate safety reporting with intelligent data aggregation, risk-benefit analysis, and automated generation of regulatory safety reports
Signal Detection and Communication
Leverage AI-powered pharmacovigilance to detect safety signals early, prioritize risks, and facilitate rapid communication with stakeholders
Integrated QMS Module
Achieve operational excellence with ISO-compliant quality management, automated process monitoring, and continuous improvement tracking
Medicine Information Center
Empower informed decisions with comprehensive drug databases, interaction checkers, and instant access to regulatory and clinical information
Law Enforcement Module
Combat counterfeit drugs with intelligent enforcement tracking, case management, and coordinated action planning across regulatory teams
Finance Module
Optimize revenue collection with automated fee calculation, integrated payment processing, and comprehensive financial analytics and reporting
Business Intelligence & Analytics
Drive data-driven decisions with powerful dashboards, predictive analytics, and real-time performance insights across all regulatory processes
Document Management (Alfresco)
Revolutionize document handling with enterprise-grade management, version control, collaboration tools, and secure digital archiving
Integration Layer (WSO2)
Connect seamlessly with existing systems through robust API management, ensuring data consistency and eliminating information silos
Notification Module
Keep stakeholders informed with intelligent multi-channel notifications, automated alerts, and customizable communication workflows
Dynamic Designer
Adapt to changing requirements with no-code form builders, dynamic report generators, and flexible interface customization tools
Access Control Management
Secure sensitive data with granular role-based permissions, multi-factor authentication, and comprehensive user activity monitoring
AI Validation Tool
Enhance accuracy with machine learning validation, automated data quality checks, and intelligent error detection across all modules
Application Tracker
Provide transparency with real-time application status, automated progress updates, and predictive timeline estimation for all submissions
Mobile Inspection Tool
Enable field work with offline-capable mobile inspections, photo documentation, GPS tracking, and instant data synchronization
Workflow Management
Optimize processes with configurable workflows, automated task routing, bottleneck identification, and performance optimization
eCTD Dossier System
Accelerate submissions with automated eCTD compilation, validation checking, and seamless integration with international regulatory systems
Administrative Module
Maintain system excellence with comprehensive administration tools, user management, configuration control, and zero-hardcoding architecture
Audit Module
Ensure accountability with complete audit trails, compliance reporting, forensic analysis capabilities, and automated regulatory documentation
System Architecture
Modular architecture designed for scalability, integration, and optimal performance
Customer Portal
Self-service portal for pharmaceutical companies to submit applications and track progress
Internal Staff Portal
Comprehensive dashboard for regulatory staff to manage reviews and approvals
Mobile App
Field inspection and offline data collection mobile application
DMS System
Enterprise document management system with version control and collaboration
AI Engine
Machine learning and artificial intelligence for validation and decision support
Integration API Manager
Centralized API management for seamless system integrations
Report Server
Advanced reporting engine with business intelligence capabilities
eSignature Platform
Digital signature solution for all system correspondences and external documents with legal compliance
Key Value Additions
Multilingual Support
Support for multiple languages and localization
Service Charter Compliance
Built-in service charter and compliance tracking
Dynamic Workflows
Configurable workflows for all regulatory processes
Inbuilt AI
Artificial intelligence for validation and decision support
Single Sign-On
Unified authentication across all system components
Fully Integratable
Seamless integration with existing systems and databases
WHO/ISO Compliant
Compliant with international standards and best practices
8+ Countries
Successfully deployed across multiple African countries
iRIMS First Version Release
Initial release of integrated Regulatory Information Management System with core pharmaceutical regulatory modules
LIMS Integration
Released Laboratory Information Management System as integrated component of the regulatory platform
iRIMS V2 Upgrade
Major system upgrade with enhanced user interface, improved workflows, and expanded regulatory coverage
iRIMS V2.5 & CTMS Addition
Upgraded to version 2.5 with addition of Clinical Trial Management System for comprehensive clinical oversight
iRIMS V3 - QMS & Mobile
Major upgrade to version 3 with integrated Quality Management System and offline mobile inspection capabilities
iRIMS V3.4 - QUALTS & Law Enforcement
Enhanced system with QUALTS integration and comprehensive Law Enforcement module for regulatory compliance
iRIMS V4 - WHO GBT Focused
Latest upgrade to version 4 with WHO Global Benchmarking Tool focus for international compliance standards
Digital Transformation & Low-Code Platform
Introduction of digital signature capabilities, iRIMS low-code/no-code subscription variant powered by Microsoft, and VNEes Dossier format for veterinary products
AI, Big Data & Web3 Integration
Cutting-edge integration of Artificial Intelligence, Big Data analytics, and Web3 technologies for next-generation regulatory management with blockchain security