Talk to us about your drug serialization project.
Tell us your regulatory markets, packaging line configuration, and current serialization approach. We'll scope the right build.
Your serialization system generating rejects and line stoppages because the camera and printer integration wasn't built for your line speed?
EPCIS reports failing trading partner validation because your current platform doesn't handle your aggregation hierarchy correctly?
Drug Serialization and Track-and-Trace Software
DSCSA enforcement in the US and FMD in the EU now require unique identifiers on every saleable drug unit and the ability to report product movement to trading partners electronically. Generic serialization platforms built for simple, single-product lines break down when manufacturers have complex line configurations, multiple markets, or CMO operations serving multiple pharma clients.
We build custom drug serialization and track-and-trace platforms for pharmaceutical manufacturers. Serial number generation, packaging line integration, EPCIS event reporting, and ERP connectivity -- built around your production environment and your regulatory market mix.
GS1-compliant serial number generation and aggregation at item, case, and pallet levels
Packaging line integration with printers, cameras, and rejection systems
EPCIS event reporting for DSCSA and FMD trading partner connectivity
SAP, Oracle, and MES integration for batch and lot data
Drug serialization software assigns unique GS1-compliant identifiers to each saleable pharmaceutical unit, aggregates serial numbers at item, case, and pallet levels, and reports product movement to trading partners via EPCIS event files. DSCSA (US) and FMD (EU) require this at every change of ownership in the supply chain. RaftLabs builds custom drug serialization platforms for manufacturers and CMOs that need packaging line integration, EPCIS reporting, and ERP connectivity built for their specific production environment.
- Regulatory compliance built in
- DSCSA + FMD
- Week delivery for serialization platforms
- 12-16
- Software products shipped
- 100+
- Cost delivery
- Fixed
Why serialization is now a manufacturing requirement, not a compliance project
DSCSA enforcement in the United States reached its final implementation milestone in November 2023. Every manufacturer, repackager, wholesale distributor, and dispenser in the US drug supply chain is now required to exchange product tracing information electronically -- with EPCIS-format event data -- at every change of ownership. The EU Falsified Medicines Directive has required serialization and verification for prescription medicines since 2019. Markets in China, South Korea, Saudi Arabia, Turkey, and Brazil have introduced comparable requirements on their own timelines.
The consequence is that pharmaceutical manufacturers without a working serialization system are locked out of their trading partner networks. A manufacturer that cannot produce a compliant EPCIS ship event when product leaves the facility cannot sell to a major US wholesaler. A product that cannot be verified against the EU Medicines Verification System cannot be dispensed at a pharmacy.
Generic serialization platforms handle standard configurations well enough. The failures appear when a manufacturer has multiple production lines with different equipment vendors, when a CMO manages serialization on behalf of multiple pharma clients with separate lot numbering ranges, or when a company operates across markets with different regulatory requirements and different EPCIS event schemas. Custom-built serialization software handles these configurations because the aggregation hierarchy, line controller integration, and event reporting rules are designed around the actual production environment rather than adapted from a one-size-fits-all template.
What we build
Serial number generation and aggregation
Serial numbers are generated in GS1-compliant SGTIN format and assigned at item, case, and pallet levels according to the aggregation hierarchy your supply chain requires. The system maintains the parent-child relationships between packaging levels so a pallet serial number carries the full record of the cases it contains and the items within each case. Lot number, expiry date, and batch record identifiers are bound to each serial at point of generation. Number pools are managed per product and per market so DSCSA and FMD number ranges are kept separate without manual intervention. Serial number status tracking covers the full lifecycle from generation through commissioning, shipping, and destruction -- with decommissioning workflows for product that is rejected, returned, or recalled.
Packaging line integration
Line integration connects the serialization system to the printers, cameras, and rejection systems on each packaging line through the line controller. Print commands carry the serial number, 2D DataMatrix code, and human-readable text formatted to the packaging artwork specification. Camera inspection results -- code quality grade, readability confirmation, and data verification against the serial number issued -- are captured at each inspection point and stored against the serial record. Rejection system commands are triggered automatically when a code fails inspection so unreadable or non-conforming packs are removed from the line without manual intervention. Line speed, reject rate, and camera pass rate are logged per batch so quality teams have production data for deviation investigations without manual line log reconciliation.
EPCIS event reporting
EPCIS events are generated for each supply chain transaction -- commissioning at the packaging line, aggregation as cases and pallets are built, shipping when product leaves the facility, and receiving when trading partner responses confirm delivery. Events are formatted to the EPCIS 1.2 or 2.0 schema required by the trading partner and transmitted via AS2, SFTP, or API depending on the connection method each partner supports. For DSCSA, the system produces the Transaction Information, Transaction History, and Transaction Statement required for each saleable unit exchange. For FMD, events are transmitted to the national competent authority repository in the required format. Trading partner onboarding workflows manage the connection configuration, message testing, and acknowledgement handling for each new partner.
Product verification portal
Wholesalers and distributors with verification obligations under DSCSA can query product status through a verification portal that checks the serial number, lot, expiry date, and NDC against the manufacturer's serialization database. Queries return a verified, suspect, or not-found response in the format the Drug Supply Chain Security Act requires. For the EU, the portal supports verification lookups against the national medicines verification system endpoint relevant to each market. SNOMED and GS1 product identifiers are supported alongside proprietary product codes so queries can be submitted using the identifier format the verifying party holds. Verification query logs are retained with timestamp, querying party, query result, and product details for regulatory audit purposes.
Suspicious product alert management
When a verification query returns a suspect or not-found result, or when a trading partner submits a suspect product report, the alert management system creates a quarantine record linked to the affected serial numbers. The quarantine workflow notifies the responsible quality team, locks the affected serials from further shipping transactions, and opens an investigation record. Investigation steps, findings, and disposition decisions are recorded against the case with a full timestamp and user audit trail. Where the investigation confirms a falsification or supply chain integrity breach, the system generates the regulatory notification content required by DSCSA or FMD in the format each authority requires. Alert age tracking and escalation rules ensure open investigations are assigned and progressed within your defined response time commitments.
ERP integration
Batch and lot data from SAP, Oracle, or your manufacturing execution system is the authoritative source for the product identity information bound to each serial number. The integration layer pulls batch release status, lot expiry, and product master data from your ERP at the point serialization is triggered so there is no manual re-entry of batch data into the serialization system. Completed batch serial number records are written back to the ERP and MES so your quality and inventory systems carry the full serialization data for each batch. For CMO operations managing multiple pharma client products, the integration supports separate client ERP connections with product and lot data kept isolated per client. Reconciliation reports confirm that the serial count in the ERP matches the commissioned serial count in the serialization system for each batch.
Frequently asked questions
Drug serialization is the process of assigning a unique identifier -- typically a GS1 SGTIN encoded as a 2D DataMatrix barcode -- to each individual saleable unit of a pharmaceutical product and recording the movement of that unit through the supply chain. It is required because regulators in the US (DSCSA), EU (FMD), and a growing number of other markets have mandated unit-level traceability as a tool against drug counterfeiting and diversion. Under DSCSA, manufacturers must serialize each saleable unit, aggregate serials across packaging levels, and exchange product tracing information electronically with their trading partners at each change of ownership. Under FMD, each pack must carry a unique identifier that can be verified against a national medicines verification repository at the point of dispensing. A manufacturer that cannot produce compliant serial numbers and EPCIS event data cannot legally sell product in these markets.
SAP Advanced Track and Trace for Pharmaceuticals and Tracelink are the dominant packaged solutions in this space. They handle standard configurations well and are the right choice for manufacturers whose packaging lines, trading partner mix, and regulatory markets fit the out-of-the-box configuration. The cost and complexity of these platforms becomes a problem for mid-size manufacturers and CMOs whose requirements don't fit the standard model. SAP ATTP requires a full SAP environment and extensive configuration by SAP specialists -- the licensing and implementation cost is substantial. Tracelink is a SaaS platform with per-serial pricing that scales with volume in ways that can make high-volume generics manufacturing expensive over time. A custom platform built around your specific line configuration, aggregation rules, and trading partner connections costs more to build initially but has no per-serial fees, no dependency on a third-party vendor's product roadmap, and can be configured precisely to the markets you operate in. We'll tell you directly if a packaged solution would serve your situation better than a custom build.
Integration depends on what your line controllers, printers, and cameras support. Most major packaging line vendors -- Bosch, IMA, Uhlmann, Marchesini -- expose integration points through their line controller that allow a serialization system to send print commands and receive inspection results. Printer vendors including Videojet, Markem-Imaje, and Domino have documented interfaces for receiving serial number data. Camera systems from Cognex, Omron, and similar vendors provide inspection result outputs that the serialization system can capture. We assess your specific equipment and line controller setup during project scoping to confirm the integration approach. If your line controller has a proprietary interface, we've built adapters for those situations -- the integration design is part of the scoping work, not an assumption.
A serialization platform for a single production line covering serial number generation, line integration, EPCIS event reporting, and ERP connectivity typically runs $60,000 to $120,000 depending on the number of trading partner connections, ERP integration complexity, and whether the build includes a product verification portal. Multi-line builds and CMO platforms supporting multiple client products are priced based on scope. The cost is fixed before development starts. There are no per-serial fees or ongoing licensing costs beyond any hosting infrastructure. We scope every project before pricing it so the number you agree to is based on your actual requirements, not a bracket estimate.
What clients say
What our clients say
Three-year average engagement. Founders and operators describing the work in their own words. No marketing varnish.
Charles E.
Entrepreneur at Aggie Technologies
All of the sprints were completed on schedule and on budget. We highly recommend RaftLabs!
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