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CASE STUDY

Driving Operational Excellence: Optimizing a Quality Management System for a State-of-the-Art Biomanufacturing Facility

Background

Syner-G Biotech Consulting recently partnered with a global leader in nucleic acid and mRNA production to implement an optimized Quality Management System (QMS) for their newly established commercial manufacturing facility. This state-of-the-art expansion featured three advanced manufacturing lines and a sterile fill-finish suite, requiring seamless cross-functional coordination to achieve operational readiness within a tight deadline. To ensure compliance with regulatory requirements while supporting efficient engineering operations, the client sought to refine and evolve their existing QMS. Leveraging deep expertise in quality management and regulatory compliance, Syner-G’s team of experts delivered a custom solution, navigating tight timelines and operational intricacies to drive the project to success.

Challenge

Solution

Results