EU MDR compliance support for a Global Medical Device Manufacturer
RIM Data Management & Compliance Support for a Mid-Sized Pharmaceutical Company
Project Summary
A mid-sized pharmaceutical company partnered with Celegence to strengthen its Regulatory Information Management (RIM) capabilities. The client’s RIM system was underutilized, leading to inefficiencies in data entry, reporting, and governance. Celegence provided end-to-end RIM support to enhance data integrity, streamline processes, and improve global regulatory operations—transforming the system into a strategic compliance and efficiency tool.
Challenges Faced by the Client
Maintaining accurate and complete data within the RIM system
Managing global submissions including initials, variations, and renewals
Handling commitments and Health Authority queries efficiently
Identifying process bottlenecks and reporting gaps affecting timelines
Highlights:
Managing high-quality data for global regulatory submissions
Tracking and maintaining commitments, obligations, and Health Authority queries
Generating customized reports for downstream regulatory and business processes
Conducting regular data quality checks to ensure accuracy and integrity
Implementing process improvements to reduce manual effort and enhance efficiency
Project Achievements
Enhanced data accuracy, quality, and compliance across regions
Strengthened data governance and regulatory readiness
Enabled faster turnaround times and greater visibility through optimized reporting
Empowered the client to leverage their RIM system as a strategic compliance platform rather than just a data repository
Project Success
The success of this engagement was driven by Celegence’s strong process knowledge, technical RIM expertise, and collaboration with the client’s global teams. By implementing best practices and data governance models, Celegence helped the client transform their RIM system into a robust compliance and operational excellence framework..
Need RIM Support for Better Compliance and Efficiency?
Celegence offers regulatory data management, system optimization, and process improvement solutions to help pharma companies strengthen compliance and drive efficiency. 📧 Email us at info@celegence.com
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16 Oct, 2025
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