China Serialization and Reporting Compliance Solution Launched
TraceLink Inc., the leader in pharmaceutical serialization, track and trace and supply network towers for global Life Sciences, announced today the first end-to-end China pharmaceutical serialization and government reporting solution for the Life Sciences supply chain. Now in commercial use by multiple top-20 pharmaceutical companies to meet China compliance laws, TraceLink’s integrated applications on the TraceLink Life Sciences Cloud network platform deliver secure compliance and ensure market access for companies across the globe facing current China regulations and emerging 2015 deadlines.
“China is a key example of the strategic business challenges facing the global Life Sciences industry today, namely how to ensure access to fast growing consumer markets when faced by complex track and trace compliance requirements,” said Shabbir Dahod, President and CEO of TraceLink. “By 2017, over 75 percent of all pharmaceuticals produced will need to meet one or more serialization, traceability or reporting regulations across the globe. Our China compliance solution delivers on our vision to take complicated, uncertain regulatory burdens like these off the shoulders of our customers and enable them to efficiently deliver medicines to the patients who need them.”
China’s track and trace laws mandate serialization, event tracking from production through distribution and compliance reporting to the China CFDA for all pharmaceuticals by December 31, 2015. Initial phases of China’s track and trace laws are already in force. Due to custom China serial number formats, detailed reporting requirements and numerous file and data management challenges, pharmaceutical companies and CMO/CPOs producing drugs for the China market face immense complexity in meeting these unique regulations.
In response, TraceLink has deployed a comprehensive, modular compliance solution that meets China regulations out-of-the-box while providing for global track and trace regulatory support on a single harmonized platform:
- Serial Number Manager. Upload and management of custom China EDMC serialization codes created by the China CFDA with full support for aggregation across multiple packaging hierarchies
- Serial Number Exchange. Integrated serial number and serialization event exchange with internal packaging line systems and external supply partners while providing for full exception management and transaction monitoring
- Serialized Operations Manager. Network EPCIS and serialization event repository with interfaces to warehouse and logistics systems, configurable operational triggers for compliance activities and management of product aggregation relationships from production and packaging through distribution
- Government Reporting. Automated generation and monitoring of China government reports for all required events with complete support for unique China file handling requirements
TraceLink also relieves the network integration challenge facing companies needing to share China serialization information and supply chain events with diverse global supply partners. TraceLink’s Amazon AWS-based cloud platform provides “integrate-once, interoperate-with-everyone” transaction translation capabilities enabling information sharing between a company and its entire supply network through a single integrated connection. TraceLink’s Network Services team finishes the job by onboarding all supply partners not already on the TraceLink Network on behalf of our customers. As a result, TraceLink completely eliminates the massive cost and risk of developing custom B2B connections with dozens to hundreds of supply partners to meet impending compliance deadlines.
Today, TraceLink is trusted by companies across the Life Sciences supply chain, including nine of the top 20 pharmaceutical companies and over 47,000 dispensing endpoints, to ensure regulatory compliance, monitor drug quality and profitably deliver needed medicines to patients across global markets. Through a single connection to our Life Sciences Cloud platform, TraceLink enables companies to meet not just China but also US DQSA, Brazil, Argentina and other global regulations securely and efficiently regardless of company size and supply network complexity.
Learn more about TraceLink’s China compliance solutions, watch this educational webinar on China serialization regulations or contact TraceLink to see how we can reduce your cost, risk and time in meeting China and other global track and trace regulations at www.tracelink.com.
TraceLink protects patients, enables health, grows profits and ensures compliance for companies across the global Life Sciences network through the TraceLink Life Sciences Cloud. The TraceLink Life Sciences Cloud is an Amazon AWS-based cloud application platform enabling complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud delivers the information, insight and collaboration needed to improve performance and reduce risk across global supply, manufacturing and distribution operations. Winner of numerous industry awards including the Amazon AWS Global Start-Up Challenge Grand Prize and the Edison Award for Innovation in Health Management, the TraceLink Life Sciences Cloud is relied upon by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost. For more information on TraceLink and our solutions, visit www.tracelink.com.
TraceLink is funded by FirstMark Capital. FirstMark Capital is an early stage venture capital firm based in New York City. FirstMark’s mission is to partner with exceptional entrepreneurs who are changing the world by solving meaningful problems. FirstMark has built a deeply engaged community among the extraordinary teams in the FirstMark network to spread ideas and opportunities. FirstMark is privileged to work alongside the founders of remarkable businesses like Pinterest, Lumosity, Aereo, TapAd, Shopify, Riot Games, and dozens more. Visit FirstMark in New York City or online at firstmarkcap.com and @FirstMarkCap.