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Global Compliance

Single platform to manage the unique compliance requirements of the United States, European Union, India, China, Russia, South Korea, and Brazil. Expertise on evolving regulations, and continuous monitoring of changes. Platform architecture that immediately delivers required updates to all customers. Achieve compliance across markets with the least amount of time, cost, and risk.

Benefits

  • Global requirements managed on one platform. Advanced business logic and rules to create and transmit the right information in the required formats to government authorities.

  • Singular focus on life sciences track and trace. Singular focus on life sciences track and trace. Global team of 438 entirely focused on monitoring, implementing, and supporting the unique requirements of different markets.

  • Trade requirements command equal attention. Support for supplier and customer demands made in response to regulatory changes.

  • Network tenancy to support seamless updates. Architecture that seamlessly pushes software updates to all customers, with no effort from them.

  • Continuous compliance, guaranteed. Confidence that compliance can be achieved, and maintained, eliminating risk for your business.

Use Cases

United States Compliance
Enables pharmaceutical companies, repackagers, wholesale distributors, and hospitals and pharmacies to meet the serialization, verification, and transactional information exchange requirements of the Drug Supply Chain Security Act (DSCSA).

European Union Compliance
Supports pharmaceutical Marketing Authorization Holders (MAHs) in sending required data to the EU Hub and managing all other essential interactions, while the Pharmacy Application gives pharmacists a secure and reliable way to meet all their EU FMD requirements.

India Compliance
Purpose-built for DAVA compliance for exported product, delivering complete compliance data management, DAVA report generation, and exception management.

China Compliance
Supports the market's unique requirements, including the use of non-standard, China-specific identifiers; governmental involvement in serial number generation and report submissions; and significant complexity across product, production, and supply chain reporting.

Russia Compliance
Comply with Federal Law No. 425-FZ's evolving serialization and reporting requirements, managing serialization and traceability of medicines from manufacturer to patient, and reporting product and transaction events to the central government system.

South Korea Compliance
Produce the unique, required reporting for specialized and over-the-counter (OTC) products, and integrate with the Korean Pharmaceutical Information Service (KPIS) for reporting submissions.

Brazil Compliance
Meet the requirements of law No. 13.410 with a partner who has worked closely with industry associations and GS1 Brazil to help define the country’s traceability landscape.

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