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End-to-End RIM Data Management for a Large 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

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Timely registration of updates in the RIM system in accordance with SOPs, WIs, and QDs

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Delivered on-demand and periodic reports, providing visibility into global regulatory activities

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Conducted quality checks on RIMS entries to maintain data integrity

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Ensured compliance with evolving EMA requirements using RIM and SharePoint workflows

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Provided regulatory expertise to capture new data requirements and support system/process evolution

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Performed verification and quality assessments aligned with corporate standards

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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

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Managing ~4,500 regulatory data requests per year

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Maintaining accuracy across ~170 critical, region-specific data fields

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Converting mass Excel-based updates into compliant RIM formats

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Ensuring data quality across global systems under tight deadlines

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Adapting to evolving regulatory and business requirements

Highlights:

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Successfully processed and maintained 4,500+ requests annually with accuracy and timeliness

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Improved data quality, integrity, and visibility across global records

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Reduced manual effort and errors through process automation and structured reporting

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Enabled faster mass updates with fewer discrepancies

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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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