Automation of Regulatory Document Validation and Stakeholder Notification System for Pharmaceutical Compliance

The client faces significant delays and inaccuracies in verifying medicinal dossiers during registration and renewal processes, with manual validation taking multiple days and prone to errors. Additionally, manually reporting and updating stakeholders with regulatory information consumes substantial human effort and time, hampering operational efficiency and increasing rework risk.

A large, global pharmaceutical enterprise with a century-long market presence, managing an extensive portfolio of medicines across multiple regions, seeking to optimize its regulatory compliance processes.

• Enhance operational efficiency by establishing transparent, rule-based workflows for medicine registration and renewal processes.
• Reduce dossier due diligence time from several days to a few hours through process automation.
• Minimize personnel time spent on dossier validation by automating compliance checks and notification workflows.
• Improve the accuracy and consistency of submitted documents to regulatory authorities, reducing rework and submission errors.
• Streamline stakeholder communication by automating regulatory updates and information distribution across multiple regions.

• Automated validation of medicinal dossiers, including document availability and content compliance based on predefined rules and patterns.
• Rule-based compliance checks configurable for different regions/countries, including assessment of document structure, molecular formulas, and regulatory requirements.
• Integration with external systems to import medicine data and export validation results seamlessly.
• AI-assisted content analysis through machine learning models for complex document content recognition.
• User interface for managing workflows, reviewing validation results, and overseeing task progress.
• Task management engine to assign, transfer, and track validation tasks between humans and bots.
• Automated notification system to inform stakeholders about registration, renewal, and variation statuses.
• Reporting dashboards for regulators, compliance teams, and management to monitor process effectiveness.

• Regulatory document repositories or corporate document management systems
• Product tracking and registry systems for medicine data acquisition
• Communication channels such as email or internal messaging platforms for stakeholder notifications

• High scalability to handle increasing regional regulatory rules and growing document volumes
• Fast response times, with dossier validation processes completed within hours
• Secure access control with role-based permissions and data encryption
• System availability of 99.9% uptime to support global operations
• Ease of customization to incorporate new rules and workflows efficiently

The implementation of automated dossier validation and stakeholder notification is expected to substantially reduce processing times from days to hours, decrease error rates and rework, and increase overall compliance accuracy. This will enable the client to accelerate medicine registration cycles, improve regulatory reporting efficiency, and optimize resource allocation across global regions.