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Global Compliance

India

Comply with India’s track and trace regulations for exported product with a complete, end-to-end solution for pharmaceutical companies and CMOs. The TraceLink India Compliance module is purpose-built for DAVA compliance, delivering complete compliance data management, DAVA report generation, and exception management. Reduce the time, cost, and risk associated with achieving compliance in India.

Benefits

  • Barcoding and serialization. Uniquely serialize drug products at the tertiary (case), secondary (saleable unit), and mono-carton packaging levels, adhering to the different data capture requirements for each level.

  • Aggregation. Create aggregation relationships across all packaging hierarchies — including tertiary, secondary, and primary (if so encoded) — and maintain those relationships.

  • Trade partner on-boarding. Meet trade partner requirements for integration including initial set up and ongoing support.

  • Reporting. Produce required reporting on events, including product master data, batch pre-production, and production/packaging actions.

  • Exemptions. Notify the India government about products intended for export that will follow the serialization laws for their export market, thus exempting them from India export laws.

Applications

India Compliance
India Compliance allows pharmaceutical companies to produce all DAVA-required submissions. When products are manufactured and packaged, the TraceLink application enables all product details, serialized identity across all required pack levels, and aggregation information to be captured and configured into XML reports which are then submitted to the India Drug Authentication and Verification Application (DAVA) portal.

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