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Product overview
Comply with South Korea serialization and reporting requirements
TraceLink South Korea Pharmaceuticals solution provides comprehensive end-to-end support for pharmaceutical companies looking to meet South Korea’s serialization and compliance reporting regulations.
With South Korea Pharmaceuticals, you can:
Industry challenges
New compliance requirements demand new compliance solutions
Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving requirements in South Korea. These challenges include:
Management of master data for reporting
In South Korea, reporting is required across a broad range of pharmaceutical products, including normal pharmaceuticals and special classes of pharmaceutical products, each with special handling requirements and unexpected data submission fields such as unit price.
Management of master data for reporting
Separate product/shipment and serialization data templates
Separate product/shipment and serialization data templates create challenges in ensuring correct linkage, submission, archival, and retrieval for pharmaceutical companies.
Separate product/shipment and serialization data templates
Disjointed communication during reporting
Extensive error checking during report submission and asynchronous response messages create complexities for both report management and operational processes.
Disjointed communication during reporting
Capabilities
TraceLink South Korea Pharmaceuticals
South Korea Pharmaceuticals provides the advanced compliance data management and reporting capabilities critical in keeping your business in compliance with South Korea regulations, while maintaining operational efficiency across production and distribution operations.