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Regulatory Dossier Automation Platform for Global Pharmaceutical Compliance

itransition.com

Medical

Regulatory Compliance

Life Sciences

Operational Inefficiencies in Regulatory Compliance

Manual verification of 300+ document medicine dossiers against health authority regulations consumes 5+ days of pharmacist effort per dossier. Time-consuming stakeholder notifications and error-prone processes delay regulatory registrations and increase rework costs.

About the Client

Multinational pharmaceutical company with 1000+ products across therapeutic areas, operating in EMEA and APAC regions

Automation Goals for Regulatory Excellence

Reduce dossier due diligence time from days to hours through automation
Implement rule-based workflow management for regulatory processes
Automate 90%+ of compliance checks and stakeholder notifications
Improve submission accuracy to reduce regulatory rework by 75%
Establish scalable framework for global expansion across 50+ countries

Core System Capabilities

Automated dossier structure validation using RegEx and ML models
Rule-based compliance checking engine with 500+ configurable rules
Multi-stage workflow management (Registration/Variation/Renewal)
Stakeholder notification automation via email integration
Customizable dashboards with compliance status tracking
Document Understanding AI for structured/unstructured data extraction
Role-based access control with audit trails

Technology Stack

UiPath RPA

Enate BPM

Python ML Models

RegEx

Document Understanding AI

System Integrations

Corporate product trackers
Health authority regulatory systems
Internal document repositories
Email communication platforms

Quality Attributes

Support 50+ country-specific regulatory configurations
99.9% system availability with failover capabilities
Role-based security with HIPAA/GDPR compliance
Horizontal scalability for 1000+ concurrent users
Real-time performance monitoring dashboard

Business Transformation Outcomes

Enables 80% reduction in dossier processing time, 60% decrease in compliance errors, and 40% lower operational costs for regulatory submissions. Establishes foundation for AI-driven regulatory intelligence and global market expansion capabilities.