Name: India Pharmaceuticals
Brand: TraceLink

Products

Advanced compliance data management and reporting solutions to meet India traceability compliance requirements

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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:

Confidently meet India traceability requirements

Streamline regional compliance operations and processes

Insulate internal enterprise systems from country-specific compliance demands

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

Product benefits

Accelerate integration with ready-to-go supply partners

Companies can leverage TraceLink's extensive network of pre-existing integrations with CMOs and 3PLs to speed access to key product and transaction compliance information needed for reporting.

Product benefits

Support a wide range of business use cases

The flexible TraceLink global compliance platform supports a wide range of business and operational use cases for marketing authorization holders and pharmaceutical manufacturers producing product in India for export to other global markets.

Product benefits

Ensure continuous compliance as requirements evolve

The TraceLink compliance platform is constantly updated to ensure compliance, regardless of whether companies are producing their own medicines, leveraging third-party CMOs, or taking a hybrid approach across their portfolio.

Product benefits

Scale compliance across multiple markets and regulatory standards

The India Pharmaceuticals solution provides a common global platform for compliance reporting and compliance data management to meet unique India compliance reporting requirements while serving other global traceability regulations.

Product benefits

Ease integration with other third-party enterprise solutions

Leverage TraceLink serialization applications for India serialization management and creation of product identifiers, while easily integrating with other existing third-party solutions already in place and in use.

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.

Manage workflows & data

Automate and customize reports

Analyze compliance data and reports

Utilize flexible workflows, business rules, and data configuration capabilities needed to support complex operational and supply chain requirements.

Generate XML-formatted India compliance reports for the Product Report and Export Tertiary Packaging Report.

Automate or manually generate reports.

Search, view, and and analyze compliance data and current and historical reports including in-depth information on:
Report Type
Aggregation Hierarchy
Lot Numbers
Serial Numbers
Shipment Information
Packaging Codes and other Product Information
Utilize audit trailing of submitted reports and system
responses