Pharmaceutical serialization and aggregation
- Meet EU FMD serialization requirements without investing in your own line
- Serialization and aggregation integrated into every packaging line, tracked from wallet to pallet
- One partner for secondary packaging, serialization, and GDP-compliant distribution
Serialization compliance without building your own line
Since February 2019, the EU Falsified Medicines Directive requires every prescription medicine to carry a unique 2D Data Matrix code and a tamper-evidence device. For pharmaceutical companies without in-house packaging infrastructure, that requirement turns every product launch into a serialization project: equipment, software, verification, and reporting all need to be in place before a single pack can ship. Building and validating that capability yourself takes time and budget away from your core business.
Ecobliss removes that burden. Serialization and aggregation are integrated into every packaging line in our GMP-certified facility in the Netherlands, as a standard part of full-service secondary packaging. Your packs are designed, packed, serialized, and shipped under one roof, by one team that has been doing pharmaceutical packaging for over 30 years. You get FMD compliance as part of the service, not as a separate project to manage.
What serialization and aggregation look like on our lines
Every pack receives a unique 2D Data Matrix code containing the product code, batch number, expiry date, and serial number. The code is printed at the cartoning station and the serial is uploaded to EMVO before the pack leaves our facility. Tamper-evident sealing is standard on every line, covering both safety features the FMD mandates.
Aggregation is tracked from the individual wallet through to the pallet. Each serialized pack is linked to its carton and shipping case, so logistics teams can scan one code and know exactly which packs are inside. That makes receiving faster and keeps recalls, returns, and audits manageable. You receive complete track-and-trace data, and our systems also support country-specific requirements for markets outside the EU.
Serialization that scales with your product
Much of the serialization market is built around blockbuster volumes. Ecobliss specialises in high-value, low- to mid-volume medications where every batch counts. We have no fixed minimum order quantity, and our equipment ranges from manual packaging stations for small clinical batches to fully automated lines for large commercial volumes, all with serialization and aggregation integrated. When your volumes grow, change, or shift between markets, the same team of 40 specialists adjusts with you. One point of contact, short communication lines, and a partner that treats your product as its own.
Compliance that carries through the whole product lifecycle
Serialization is not a one-off setup; it lives across artwork changes, market extensions, and volume shifts. Ecobliss manages artwork collaboration through a blockchain-protected document management system with real-time access for approvals and full audit trails. Finished goods are stored in our GDP-compliant warehouse, with licensed handling of Schedule I and II controlled substances where required. And because serialization runs on every line, moving from clinical batches to commercial supply does not mean requalifying a new serialization setup: the same facility and the same team carry your product forward.
What to expect from your serialization project
Intake and compliance assessment
We review your product, dosage form, target markets, and current packaging setup. Within one week you receive a packaging assessment covering the recommended secondary packaging format, the serialization and aggregation approach for your markets, and a realistic timeline.
Design and prototyping
Our in-house design team develops the packaging design and artwork, including the placement of the 2D Data Matrix code and tamper-evidence features. You receive physical prototypes to evaluate before production tooling is committed. Typical turnaround: 5 to 10 working days.
Serialized production
Your product is packed in our GMP-certified facility with serialization integrated into the line and quality inspection as standard. Serials are uploaded to EMVO before packs leave the facility, and aggregation is tracked from the individual pack through to the pallet.
Storage, distribution, and data
Finished goods are stored in our GDP-compliant warehouse and shipped to your distribution network on schedule. You receive complete track-and-trace data for your supply chain, with real-time batch tracking keeping you informed throughout.
Get serialization off your project list
Tell us about your product, your target markets, and your volumes. Our team will assess your serialization and secondary packaging requirements and come back with a tailored proposal within one week. No obligations, no generic templates.
Questions procurement and QA managers ask about serialization
Is your serialization compliant with the EU Falsified Medicines Directive?
Yes. FMD-compliant serialization is integrated into every packaging line. Each pack receives a unique 2D Data Matrix code with product code, batch number, expiry date, and serial number, combined with tamper-evident sealing. Serials are uploaded to EMVO before the pack leaves our facility.
Can you serialize for markets outside the EU?
Yes. Our systems also support country-specific requirements for markets outside the EU. Bring your target market list to the intake and we map the serialization and aggregation approach per market.
What does aggregation add on top of serialization?
Aggregation links each serialized pack to its carton and then to the shipping case and pallet. Logistics teams can scan one code and see exactly which packs are inside, which speeds up receiving and makes recalls, returns, and audits far easier to execute. We track aggregation from the individual wallet through to the pallet.
Do we need our own serialization equipment or software to work with you?
No. Serialization and aggregation run on our lines as an integrated part of secondary packaging. You receive complete track-and-trace data for your products without investing in your own serialization infrastructure.
Which packaging formats and dosage forms can be serialized?
We serialize the secondary packaging around all primary packed dosage forms: oral solids, vials, syringes, suppositories, and medical devices. Formats include cold seal wallets, folding cartons, blister cards, and multi-component kits.
What is the minimum batch size for serialized packaging?
There is no fixed minimum. Our lines range from manual stations for small clinical batches to fully automated lines for large commercial volumes, all with serialization integrated. You are not paying for capacity you do not need.
What certifications does the Ecobliss facility hold?
Our facility in Echt, the Netherlands is GMP-certified for pharmaceutical packaging operations and GDP-compliant for storage and distribution. We are licensed for Schedule I and II controlled substances and hold FSC certification (license C194323) for sustainable materials.
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