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Saudi Arabia Pharmaceuticals

Intelligent data management and reporting solutions to meet traceability compliance requirements in Saudi Arabia

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Product overview

Comply with Saudi Arabia serialization and reporting requirements

TraceLink Saudi Arabia Pharmaceuticals supports pharmaceutical manufacturers in meeting the Saudi Arabia requirements for serializing and reporting pharmaceutical products and their traceability transactions to the Saudi Arabia RSD drug track-and-trace system.

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With Saudi Arabia Pharmaceuticals, you can:

Confidently meet Saudi Arabia compliance requirements

Streamline regional compliance operations and processes

Insulate internal enterprise systems from regional compliance demands

Industry challenges

Understanding the need for new compliance solutions

Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving food supplement requirements in Saudi Arabia. These challenges include:

Saudi Arabia-specific business requirements

Saudi Arabia represents the next wave of markets that are developing and deploying track-and-trace regulations and systems, adding modifications to existing models to meet uniquely local patient or business requirements.

Saudi Arabia-specific business requirements
Unique compliance reporting and data needs

For multinational manufacturers and their supply partners, medicines are often globally or regionally produced, demanding standardization in data and process, while requiring unique local data elements and compliance report configurations.

Unique compliance reporting and data needs
New requirements across multiple global markets

Without a flexible global compliance platform in place, serving markets like Saudi Arabia may be both costly and prone to errors if isolated local solutions are developed.

New requirements across multiple global markets

Product benefits

How TraceLink Saudi Arabia Pharmaceuticals drives efficiency

Integrate with a broad network of ready-to-go CMOs and 3PLs

Support manufacturer and MAH use cases

Support wholesale distribution use cases

Build on top of the enterprise systems you already use

Scale compliance globally with a purpose-built platform

Wholesale-Distributor

Product benefits

Integrate with a broad network of ready-to-go CMOs and 3PLs

Leverage the extensive TraceLink network, which features pre-existing integrations with thousands of CMOs and 3PLs, to speed access to key compliance information.

For Internal 96

Product benefits

Support manufacturer and MAH use cases

Saudi Arabia Pharmaceuticals supports a wide range of business and operational use cases for marketing authorization holders and pharmaceutical manufacturers producing and distributing products within the Saudi Arabia market.

Wholesale-Distributor

Product benefits

Support wholesale distribution use cases

Saudi Arabia Pharmaceuticals supports companies with wholesale distribution use cases for the management of shipments, receipts, and other distribution operations.

For Internal 5

Product benefits

Build on top of the enterprise systems you already use

TraceLink offers flexibility in leveraging TraceLink serialization applications for Saudi Arabia or existing third-party solutions already in place.

For Internal 39

Product benefits

Scale compliance globally with a purpose-built platform

TraceLink Saudi Arabia Pharmaceuticals is integrated with a common global platform for compliance data management and reporting, enabling manufacturers to support new market requirements without reimplementing CMO or LMS integrations.

Capabilities

TraceLink Saudi Arabia Pharmaceuticals

Saudi Arabia Pharmaceuticals provides the advanced compliance data management and reporting capabilities needed for the complex master data and traceability reporting requirements of Saudi Arabia.

Manage workflows and data

Customize reports

Automate reporting

Analytics

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

Submit and exchange product and aggregation data to the Package Transfer System (PTS) via PTS Upload and PTS Download transactions in EPCIS and CSV formats to support provision of aggregation information to trade partners.

Digital documents

Configure and generate Saudi Arabia compliance reports for Supply, Import, Dispatch, Accept, Deactivate, and other transaction reports needed across multiple use cases.

Search, view, and analyze submitted reports with rich UI.

Internal

Automate report generation and submission triggered from operational events or manual report submission to the RSD system.

Search, view, and examine both current and historical reports with full audit trailing.

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Related resources

See more resources
Preparing for Saudi Arabia Compliance Reporting

TraceLink SVP of Product Marketing, Lucy Deus, provides an in-depth review of the January 2019 Saudi…

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Saudi Distributor, TraceLink Partner to Build Integrated, End-to-End Supply…

See why SITCO Pharma chose TraceLink for its proven solutions and global experience—and how…

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COUNTRIES

Compliance around the globe

Explore specific country compliance solutions offered to the TraceLink network.

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Country Compliance for Pharmaceuticals

Join the global compliance special interest group

Inform your global compliance strategy through this monthly tour of track-and-trace developments throughout the world. Discover what is evolving in current traceability regulations and keep an eye on the future.

Join the community

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