UK-headquartered Wasdell – which offers pharmaceutical and clinical research manufacturing, packaging, technical, and distribution services – has announced a serialisation offering to comply with the Falsified Medicines Directive (FMD) in Europe, and the Drug Supply Chain Security Act (DSCSA) in the US.
The service means Wasdell can offer serialisation-compliant products globally from its UK-based facilities in Newcastle and Swindon.
The firm’s packaging and testing site in Ireland – which is due to open early next year – will also offer serialised products.
Customers can opt for aggreagtion, explained managing director of Wasdell Manufacturing, Daniel Tedham: “Equipping our lines with aggregation capabilities means we are ready to continue supplying products to the US following the 2023 deadline for three-tier parent-child relationships between barcodes and that we can deal with future aments to regulations in other markets.”
According to Tedham, the firm “made the choice to invest in…serialisation capabilities very early on.”
“We wanted to ensure we were ready well ahead of schedule to guarantee that we could effectively support current and future clients with compliance with the EU FMD, US DSCSA and other market regulations,” he added.
Just last month, Wasdell announced plans to invest £500k ($669k) in a 1,200 square-foot laboratory in Newcastle, where it will offer in-house microbiological and analytical services to customers.