RIM Data Management & Compliance Support for a Mid-Sized Pharmaceutical Company
End-to-End RIM Data Management for a Large Pharmaceutical Company
Project Summary
A large global pharmaceutical company with a diversified product portfolio partnered with Celegence to streamline and manage its Regulatory Information Management (RIM) system. With thousands of global regulatory activities each year and evolving compliance expectations, the client required a scalable solution to handle data updates, verification, reporting, xEVMPD/IDMP maintenance, and ongoing RIMS governance. Celegence provided end-to-end RIM services to improve accuracy, compliance, and operational efficiency across global teams.
Scope of Work
Timely registration of updates in the RIM system in accordance with SOPs, WIs, and QDs
Delivered on-demand and periodic reports, providing visibility into global regulatory activities
Conducted quality checks on RIMS entries to maintain data integrity
Ensured compliance with evolving EMA requirements using RIM and SharePoint workflows
Provided regulatory expertise to capture new data requirements and support system/process evolution
Performed verification and quality assessments aligned with corporate standards
Processed service requests, maintained records, corrected errors, and handled mass updates, including conversion of Excel-based data into RIM-ready formats
Challenges Faced by the Client
Managing ~4,500 regulatory data requests per year
Maintaining accuracy across ~170 critical, region-specific data fields
Converting mass Excel-based updates into compliant RIM formats
Ensuring data quality across global systems under tight deadlines
Adapting to evolving regulatory and business requirements
Highlights:
Successfully processed and maintained 4,500+ requests annually with accuracy and timeliness
Improved data quality, integrity, and visibility across global records
Reduced manual effort and errors through process automation and structured reporting
Enabled faster mass updates with fewer discrepancies
Established a scalable RIM framework aligned with global & regional compliance needs
Project Success
Celegence combined regulatory expertise, efficient workflows, and strong stakeholder collaboration to deliver a high-throughput, future-proof RIM environment. Consistent data governance and quality checks ensured long-term compliance and operational stability..
Need RIM Support for Global Regulatory Operations?
Celegence provides complete RIM data management, reporting, and quality oversight—helping pharmaceutical companies strengthen compliance while improving operational efficiency. 📧 Email us at info@celegence.com
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23 Oct, 2025
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