Serialization, Traceability, and Regulatory Compliance
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The Global Leader in Multinational Compliance
Since 2009, TraceLink has been the industry leader in delivering regulatory compliance solutions for the global pharmaceutical industry. We support compliance and product serialization requirements in more than 30 countries. With more than 280,000 trading partners on our digital supply network, TraceLink lets companies Integrate Once, Interoperate with Everyone™ for seamless data exchange and fast partner onboarding.
Track product supply with the only active-active native cloud solution with the most live customers across all segments.
Reduce CMO, 3PL, and customer integration costs through a single network connection and partner onboarding services.
Outsource complex IT requirements to a secure, cost-effective, and highly scalable native cloud implementation.
Rapidly comply with new and evolving regulatory rules, industry standards, and partner requirements.
Serialization and compliance solutions
Reduction in time to create compliance solutions
Day advance prediction window for drug shortages
United States: Will You Be Ready for DSCSA 2023?
TraceLink is a proven leader in the industry-wide effort to ensure that manufacturers, wholesale distributors, and dispensers can meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA), including all-digital data exchange, system interoperability, and trade partner authentication.
TraceLink’s Bahrain Compliance application supports marketing authorization holders and manufacturers in meeting Bahrain requirements for serializing and reporting on pharmaceutical products and their traceability transactions to the Bahrain NHRA-MVC system.
TraceLink’s Brazil Compliance application enables multinational and Brazilian domestic pharmaceutical manufacturers, and their agents, to meet Brazilian regulation and ANVISA requirements for product serialization and SNCM reporting.
TraceLink’s China Compliance application is designed to enable pharmaceutical manufacturers to meet China’s drug traceability requirements as defined in the 2019 Drug Administration Law and related National Medical Products Agency (NMPA) regulations.
TraceLink’s European Union Compliance application supports companies in creating, submitting, and managing reports and related compliance data as required by the European Union Falsified Medicines Directive (EU FMD).
TraceLink’s India Compliance application supports marketing authorization holders, manufacturers, and exporters in serializing and reporting serialized product information to the India Integrated Validation of Export of Drugs and its Authentication (iVEDA) platform.
TraceLink provides a flexible compliance data management system for the secure creation, management, and exchange of track and trace data with supply chain partners across the U.S. pharmaceutical supply chain to meet the evolving requirements of the Drug Supply Chain Security Act (DSCSA).
TraceLink’s Russia Compliance application enables marketing authorization holders and manufacturers to meet compliance data and reporting requirements of Russia Federal Law 425-FZ, including event reporting for pharmaceuticals and their related distribution.
TraceLink’s Saudi Arabia Compliance application supports marketing authorization holders, manufacturers, and other companies in meeting serialization requirements for pharmaceutical products and reporting to the Saudi Arabia RSD drug track and trace system.
Serialize & Track Your Products As They Move Around the Globe
Serialization and traceability are the foundation for multinational compliance and your ability to optimize your global supply chain. TraceLink lets you manage your serialized product, gain real-time collective intelligence, quickly execute recalls, and more.