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BOSTON, Massachusetts — September 27, 2024 — With the Drug Supply Chain Security Act (DSCSA) stabilization period ending on November 27, 2024, the TraceLink customer and trading partner community of healthcare and life sciences companies continues to demonstrate market leadership in demonstrating compliance readiness. TraceLink’s 290,000-strong B2N Integrate-Once™ network has been instrumental in supporting customers to rapidly integrate with key supply chain partners, exchange required compliance information, automate compliance processes, and mitigate operational risks.
In the past 90 days, TraceLink customers have exchanged over 6 million DSCSA Electronic Product Code Information Services (EPCIS) transactions, reflecting a significant surge in compliance activities. Impressively, 43% of all EPCIS transactions over the past 12 months occurred during this period, underscoring the momentum of compliance initiatives as companies race to meet the deadline. Additionally, 2,590 new links with supply chain partners were established, enabling over 2,010 companies and 540 customers to seamlessly exchange critical EPCIS data.
TraceLink’s customer base has exchanged more than 15 million DSCSA transactions to date, and has grown to more than 850 companies, ranging across pharmaceutical manufacturers, contract manufacturers, wholesale distributors, and dispensers. This significant increase highlights the urgency and trust that companies place in TraceLink’s ability to deliver compliance solutions swiftly and efficiently.
“Partnering with TraceLink has been transformative for Techdow in achieving DSCSA compliance at record speed,” said Bilal Khan, CEO of Techdow USA. “The TraceLink team’s expertise and commitment to customer success facilitated a seamless and rapid deployment, enabling us to meet regulatory requirements swiftly. Their responsiveness and dedication have been instrumental in enhancing the security and transparency of our supply chain, allowing us to continue delivering safe, high-quality medications to patients with full confidence.”
For organizations still concerned about their DSCSA readiness or those who have not yet started the process, there is still time to act. TraceLink’s B2N Integrate-Once™ network enables rapid compliance through a network of pre-verified trading partners, providing a streamlined path to meeting regulatory standards without operational disruption.
TraceLink has established itself as a leader in DSCSA compliance by not only enabling predictable, cost-effective integration capability but also by providing customers with a suite of resources designed to support their compliance and digital network journey through value expansion. These include:
- Network Success Management: A dedicated team that provides expert guidance and support to onboard partners quickly and efficiently, ensuring they can link to TraceLink’s network and start exchanging EPCIS transactions without delays.
- Comprehensive Training & Education: Through TraceLink University, customers have access to a full catalog of online courses, workshops, monthly newsletters, and certification classes tailored to all stages of the DSCSA compliance process.
- Monthly Community Forums: TraceLink hosts multiple monthly meetings offering manufacturers, wholesale distributors, and dispensers an opportunity to discuss DSCSA tracing and verification compliance, FDA actions, and industry initiatives, fostering collaboration and knowledge sharing.
- Companion Compliance Capabilities for Operational Excellence: TraceLink offers solutions to operationalize DSCSA compliance, including serialized receiving and shipping, drop shipment support, GTIN and pack level master data sharing, suspect product verification, compliance exception management, and automated validation.
“TraceLink is committed to helping our customers seamlessly achieve DSCSA compliance as we near the end of the stabilization period,” said Shabbir Dahod, President and CEO of TraceLink. “As companies continue to focus on meeting the DSCSA’s requirements, our suite of comprehensive solutions and support resources ensure that businesses, regardless of where they are on their compliance journey, can effectively link with supply chain partners and avoid disruptions to their operations.”
TraceLink is helping companies leverage their DSCSA investment to improve compliance exception management, digitalize their recall processes, and orchestrate other supply chain transactions. By expanding the use of their DSCSA data and network connections, companies can enhance operational efficiency and streamline critical business processes beyond compliance. For more information on how TraceLink can support your organization in meeting DSCSA requirements, visit contact us.
