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Product overview
Comply with India’s serialization and reporting requirements
TraceLink India Pharmaceuticals enables marketing authorization holders, manufacturers, and exporters to meet the requirements in India for serializing and reporting serialized product information, as well as certain traceability transactions for exported medicines to the India Integrated Validation of Export of Drugs and its Authentication (iVEDA) platform.
With India 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 India. These challenges include:
Complex product identification and traceability regulations
India has been developing new regulations for several years, primarily focused on medicines produced in India and exported to foreign markets.
Complex product identification and traceability regulations
Compliance report preparation and submission to the iVEDA system
India’s new regulations require significant acquisition and management of product master data, product identification information, and supply chain participant information that inform these reports.
Compliance report preparation and submission to the iVEDA system
Constant changes to requirements and reporting procedures
India has frequently updated and changed both the requirements and the target reporting system, requiring companies to stay agile and innovative when meeting requirements for export medicines.
Constant changes to requirements and reporting procedures
Capabilities
TraceLink India Pharmaceuticals
The India Pharmaceuticals solution provides the intelligent compliance data management and reporting system needed for the product data and export shipment reports documented in India compliance regulations.