Join us at our upcoming EU Product Launch workshop series: Key timeline milestones from phase 3 to launch taking place in San Francisco, San Diego and Seattle in September. Click here to find out more and to register.
Addressing evolving global serialisation legislation, Almac’s expert multi-disciplinary serialisation team lead the way in supporting our client partners in developing serialisation strategies to GS1 standards.
With over 9 years’ experience in developing and delivering serialisation solutions to tackle counterfeiting and facilitating traceability throughout the product supply chain; we offer the following solutions from our UK and US commercial packaging facilities:
- Serialisation strategy consultative services
From the initial stage of enquiry, our multi-disciplinary team of serialisation experts work with our client partners to outline optimal serialisation strategies to meet market requirements for their drug product, determining key considerations such as number generation & integration processes, aggregation and reporting.
- Design, review & generation of new artwork
Our specialist in-house packaging design team can review current packaging formats and advise if new artwork is required to ensure there is appropriate space on the saleable unit to apply serialised data. Generation of new artwork in-house rather than outsourcing allows Almac to streamline the approval process, saving time and money whilst ensuring that you meet fast approaching regulatory submission deadlines.
- Technical / prototype testing artwork
Ensuring your packaging and artwork is compatible for processing on our serialisation lines, we can generate and test prototype pack formats.
- Flexible serialisation solutions for all pack formats
Our serialisation lines in our UK & US commercial packaging facilities can print and verify serialised data on saleable units and secondary packaging of bottles, blisters, wallets, vials, syringes, cartons and complex medical kits.
- Tamper evidence packaging
Meeting the Falsified Medicines Directive (FMD) requirements to further secure your valuable drug product with enhanced safety features, Almac can apply tamper-evident seals on all secondary packaging.
- Serialisation to 3 levels of aggregation
Our serialisation lines in our UK & US commercial packaging facilities generate, allocate and upload unique numbers which are applied to products at each stage of packaging and tracked through the distribution process, from the saleable item level to shipper through to pallet level.
- Integration with external providers to support serialisation management and Government reporting as required
Simplifying the supply chain, our fully flexible level 3 site software can integrate with external enterprise level 4 providers such as Tracelink & Axway providing a central storage location for all serialised data (commissioned, decommissioned and event data), helping in number management and ultimately preventing number duplication.
With EU and FDA approved commercial manufacturing and packaging facilities we are able to provide end-to-end solutions for your drug product, helping you meet commercial supply timelines, mitigate risk and reduce overall product costs whilst helping to secure your supply chain.