Serialization & Track-and-Trace
End-to-end serialization, aggregation, and regulatory reporting for DSCSA, EU FMD, and global track-and-trace requirements - powered by enterprise-grade platforms integrated across every packaging line.
OVERVIEW
Pharmaceutical serialization is no longer optional - it is the foundation of compliant drug distribution worldwide. Meridan operates a fully integrated serialization infrastructure spanning all packaging lines across our three US facilities. Our serialization capabilities cover the complete lifecycle from serial number generation and application through unit-level verification, multi-level aggregation, regulatory reporting, and trading partner data exchange.
Built on enterprise platforms from Optel and Systech, our serialization systems are designed for the scale and complexity of large pharmaceutical supply chains. We support simultaneous compliance with multiple global regulatory frameworks, manage serial number pools for hundreds of products, and maintain direct data connectivity with major wholesale distributors, third-party logistics providers, and regulatory authorities. Our serialization team includes dedicated specialists who monitor evolving global requirements and ensure our systems and processes remain ahead of regulatory timelines.
US COMPLIANCE
DSCSA Compliance
The Drug Supply Chain Security Act establishes the requirements for an interoperable, electronic system to identify and trace prescription drugs distributed in the United States. Following the November 2023 implementation milestone, all pharmaceutical packages must carry a unique product identifier encoded in a 2D data matrix barcode, and trading partners must be able to verify and trace products at the package level throughout the distribution chain.
Meridan's DSCSA infrastructure supports full compliance with enhanced drug distribution security requirements, including unit-level serialization with unique product identifiers compliant with GS1 standards, verification of product identifiers upon request from trading partners, transaction information exchange in electronic format, and suspect and illegitimate product investigation and notification. Our systems generate and manage serialized National Drug Codes, apply 2D data matrix barcodes with human-readable text, and verify every serial number before product is released to distribution.
- ✓GS1-compliant unique product identifiers (GTIN + serial number)
- ✓2D data matrix barcode application and verification
- ✓Electronic transaction information and transaction history exchange
- ✓Verification router connectivity for package-level verification
- ✓Suspect and illegitimate product investigation support
EU COMPLIANCE
EU Falsified Medicines Directive
For products destined for European markets, Meridan supports full compliance with the EU Falsified Medicines Directive and the Delegated Regulation requirements. Our systems generate unique identifiers that conform to EU FMD specifications, apply tamper-evident features to packaging, and upload serialization data to the European Medicines Verification System through certified connectivity to national and supranational repositories.
We manage the complete EU FMD data workflow, from serial number generation and upload to the European Hub, through on-pack printing and verification, to post-production data reconciliation and reporting. Our processes accommodate the specific requirements of individual EU member states, including country-specific data formatting, reporting timelines, and national repository configurations. For products distributed in both US and EU markets, our systems support dual serialization formats on a single packaging line.
- ✓EU FMD-compliant unique identifier generation
- ✓European Medicines Verification System data upload
- ✓Tamper-evident feature application and verification
- ✓Dual US/EU serialization on single packaging runs
GLOBAL MARKETS
Global Serialization
Beyond the United States and European Union, pharmaceutical serialization requirements are expanding rapidly across global markets. Meridan maintains active compliance capabilities for Brazil ANVISA serialization requirements, South Korea track-and-trace regulations, China drug traceability requirements, and other emerging regulatory frameworks. Our serialization platform is designed to accommodate new market requirements as they are published, allowing our clients to enter new markets without re-engineering their packaging supply chain.
Each market has unique data formatting, reporting, and verification requirements. Our serialization team monitors regulatory developments across all major pharmaceutical markets and maintains validated system configurations for each jurisdiction. When a client needs to add a new market, we configure the required data formats, reporting connectivity, and on-pack printing specifications within our existing infrastructure, minimizing lead time and validation effort.
- ✓Brazil ANVISA (SNCM) serialization and reporting
- ✓South Korea pharmaceutical track-and-trace
- ✓China drug traceability system compliance
- ✓Scalable platform for emerging market requirements
AGGREGATION
Aggregation
Aggregation creates the parent-child relationships between individual serialized units, cases, and pallets that enable efficient product tracing and verification throughout the distribution chain. Our aggregation processes capture the linkage between each serialized unit and its immediate packaging hierarchy - from unit to bundle, bundle to case, and case to pallet - creating a complete digital record that travels with the product.
Aggregation data is critical for downstream operations including warehouse management, order picking, returns processing, and regulatory investigations. Our systems support both inferred aggregation during packaging and explicit aggregation through post-packaging scanning. Re-aggregation services are available for products that undergo re-packing, re-labeling, or re-distribution, ensuring aggregation records remain accurate throughout the product lifecycle.
- ✓Multi-level aggregation (unit, bundle, case, pallet)
- ✓Inferred and explicit aggregation methods
- ✓Re-aggregation for re-pack and re-label operations
- ✓EPCIS-compliant event reporting
PORTAL
Portal & Reporting
Our serialization portal provides clients with real-time visibility into serial number status, production progress, and compliance reporting. The portal serves as a central dashboard for serial number pool management, enabling clients to monitor commissioned, applied, and decommissioned serial numbers across all products and packaging sites. Production reporting provides batch-level serialization summaries, exception reports, and audit trails that support both internal quality review and regulatory inspection readiness.
Regulatory reporting capabilities include automated submission of required data to government authorities and national repositories. The portal supports configurable report generation for DSCSA transaction data, EU FMD status reporting, and market-specific compliance documentation. Role-based access controls ensure that each client user sees only their authorized data, while maintaining full audit trail integrity across the platform.
- ✓Real-time serial number pool management
- ✓Production and batch serialization reporting
- ✓Automated regulatory data submission
- ✓Role-based access with full audit trail
CONNECTIVITY
Data Exchange
Effective serialization requires seamless data exchange between trading partners. Meridan maintains established EDI and API-based connectivity with major wholesale distributors, third-party logistics providers, and pharmaceutical manufacturers. Our data exchange infrastructure supports EPCIS event messages, ASN (Advanced Shipping Notice) integration, and direct master data synchronization with client ERP systems.
We support multiple data exchange standards and protocols, including AS2, SFTP, and web service APIs, configured to match each trading partner's technical requirements. Our integration team manages the onboarding and testing of new data connections, ensuring validated, production-ready connectivity before the first serialized shipment. Ongoing monitoring and exception management ensure data flows remain reliable across the supply chain.
- ✓EDI and API-based trading partner connectivity
- ✓EPCIS event messaging
- ✓AS2, SFTP, and web service protocols
- ✓ERP master data synchronization
TECHNOLOGY
Technology Platform
Our serialization infrastructure is built on enterprise-grade platforms from the pharmaceutical industry's most trusted technology providers. These systems are fully validated and maintained under our computer system validation program, ensuring data integrity, system availability, and regulatory compliance at every level.
Serialization Technology Stack
Line-Level Systems
- Optel Vision
Line-level serialization, inspection, and aggregation - Systech UniSeries
Serialization management and print-and-verify - Cognex DataMan
High-speed barcode reading and verification
Enterprise Systems
- Optel Verify / Optchain
Enterprise serialization management and reporting - Systech UniTrace
Global compliance management and data exchange - GS1 EPCIS Repository
Event-based traceability data management
Compliance & Certifications
- •DSCSA compliant (all packaging levels)
- •EU FMD / Delegated Regulation 2016/161
- •GS1 certified data formatting
- •21 CFR Part 11 compliant systems
- •Validated per GAMP 5 guidelines
- •SOC 2 Type II security controls
Related Resources
View Case Study: Multi-Market Serialization RolloutReady to optimize your packaging operations?
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