As DSCSA enforcement in the US becomes a reality after years of phased implementation, the FDA continues incorporating nuances to requirements and timelines. However, when exemptions for small dispensers and other special circumstances end, companies must be compliant with end-to-end US traceability requirements, EU FMD directives, and potentially other standards that are currently advancing around the globe.
The focus of Life Science manufacturers is now shifting beyond serialization implementation to include managing an efficient ongoing program that maintains compliance and unlocks additional business value.
Converge Consulting practitioners understand the complexities of preparing your commercial supply chain in full compliance with serialization requirements. Our specialists can also monitor your transaction data and work with you to manage and resolve exceptions. Additionally, our experts can guide you in analyzing your serialized product data to develop transformational business strategies that improve patient outcomes.
This info sheet details Converge’s approach to serialization – ensuring compliance and enhancing business value with a strong base of operational support.