Scalable Regulatory Information Management Platform for Pharmaceutical Compliance

The client faces complex and constantly changing regulatory requirements across multiple regions, necessitating frequent updates, monitoring, and comprehensive testing of their legacy RIM systems. The inflexibility of existing architecture hampers timely updates and compliance adherence, risking delays in drug approvals and increased operational costs.

A large global pharmaceutical company specializing in drug development and regulatory submissions seeking a robust, compliant, and scalable RIM platform to streamline submission processes and adapt to evolving international regulations.

• Enhance system scalability and flexibility to accommodate diverse and evolving regulatory standards across regions.
• Implement automated monitoring and testing to ensure ongoing compliance and system integrity.
• Improve integration capabilities with external regulatory data sources and document management systems.
• Reduce system downtime and improve performance through modernization and optimization.
• Ensure compliance with international standards such as FDA, EMA, and local authorities, including standards like IDMP and eCTD.
• Facilitate continuous product improvement through user feedback and agile development.

• Automated submission planning, publishing, and management workflows.
• APIs for seamless data exchange and compliance with standards such as IDMP.
• Integration with document management systems and external databases.
• Role-based secure user access and centralized authentication via LDAP.
• Real-time data monitoring and reporting dashboards, including regional and statistical analyses.
• Advanced search, version control, and audit trail functionalities.
• Automated updates reflecting evolving regulatory norms and standards.

• Regulatory data sources and external databases (e.g., Oracle).
• Document management systems for storage and retrieval of pharmaceutical documents.
• Security services such as LDAP for centralized user management.
• Analytics and reporting tools like Power BI.
• Systems for regulatory standards compliance like IDMP and eCTD.

• System scalability to support over 10,000 users and processing of 500,000 documents annually.
• High system performance with minimal downtime, utilizing cloud monitoring and root cause analysis.
• Strict security protocols, including secure access control and data protection standards.
• Compliance with international regulations such as FDA, EMA, and IDMP standards.
• Flexible architecture to support rapid updates and customization.

The implementation aims to significantly improve the client's regulatory submission workflows, leading to faster drug approval times, enhanced compliance adherence, and increased operational efficiency. The platform is expected to support over 50 enterprise clients, including top-tier pharmaceutical companies, processing upwards of 500,000 documents annually, with a support team of over 70 specialists providing continuous IT support and system enhancements.