TraceLink Partners with Saudi Azm to Help Pharmaceutical Manufacturers Comply with Saudi Arabia Aggregation Requirements
NORTH READING, Mass., Nov. 25, 2019 /PRNewswire/ -- TraceLink, a network-based platform company with the world's largest integrated digital supply network, today announced its partnership with Saudi Azm, a leading system integrator and IT solutions provider to pharmaceutical businesses in the Kingdom of Saudi Arabia (KSA). The partnership is intended to help pharmaceutical companies successfully comply with the aggregation and reporting regulations required by the Saudi Food and Drug Authority (SFDA).
Certified by the SFDA, Saudi Azm has helped numerous stakeholders onboard and report serialized medicine to the SFDA since 2018 when product serialization went into effect. As of October 1, 2019, all companies who manufacture and distribute product to the KSA market must aggregate serialized product, requiring all individual saleable units to have an identity or data relationship to the packaging case in which they are shipped. As the global compliance leader in track and trace, and through its partnership with Saudi Azm, TraceLink helps companies manage the full range of SFDA serialization requirements. Additionally, TraceLink's platform provides the performance, tools, and workflows to handle the complexities of product aggregation.
"The Saudi Arabia Drug Code (SDC) requirements introduced serialization into the region in 2018 but created a number of challenges for the pharmaceutical industry, therefore, the introduction of aggregation was a huge milestone," said Mohammad AL Kiswani, Business Development at Saudi Azm.
"The timescale was incredibly ambitious leaving only a matter of months for the industry to educate all 14,000+ stakeholders in the Kingdom on the requirements and for businesses to implement solutions, understand how aggregation would impact operations and create plans to manage the change. TraceLink's demonstrated experience and expertise helped remove many of the complexities associated with implementing product aggregation for our clients," continued AL Kiswani.
"TraceLink is able to help businesses throughout Saudi Arabia's drug supply chain build a comprehensive approach to SFDA requirements, and by partnering with Saudi Azm, we are able to alleviate much of the burden of meeting aggregation deadlines by utilizing our proven compliance platform, giving companies a significant advantage over implementing customized solutions," said Shabbir Dahod, president and CEO, TraceLink. "Our partnership allows customers to benefit from TraceLink's expertise as they prepare for their long term serialization management and reporting requirements while benefitting from local capabilities and resources."
TraceLink's scalable network platform helps pharmaceutical companies comply with country-specific track-and-trace requirements such as those in Saudi Arabia and currently serves more than 1,300 customers across 50 countries. To learn more about how TraceLink can help companies incorporate their Saudi Arabia aggregation and reporting requirements into their overall global compliance strategy, go to:
https://www.tracelink.com/insights/leveraging-your-global-compliance-strategy-in-saudi-arabia
Additional Resources:
- Download a guide to the KSA's compliance requirements
- Understand how aggregation will impact operations for businesses in the KSA and how you can prepare
- Read the latest regulatory updates from the SFDA
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About TraceLink
TraceLink is a network-based platform company that leverages its digital supply network and digital network platform to bend the supply chain around the patient. Through its industry-leading digital supply network, the TraceLink Digital Network Platform can enable seamless data sharing and process orchestration across the entire healthcare industry, enabling the creation of a real-time, patient-driven supply network. Leading life science companies, hospitals and retail pharmacies trust TraceLink to deliver complete global connectivity, visibility and traceability of pharmaceuticals, ensuring that every patient gets the medicines they need, when they need them, safely and securely. For more information on TraceLink and our solutions, visit www.tracelink.com.
TraceLink is funded by Georgian Partners, Willett Advisors LLC, Vulcan Capital, Goldman Sachs, FirstMark Capital, Volition Capital and F-Prime Capital.
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