The Wasdell Group (Wasdell) has launched its serialisation service ahead of the EU FMD and US DSCSA implementation deadlines.
Wasdell, an outsourcing partner to companies within the pharmaceutical, medical device and clinical trials industries,
Following a £2.8 million investment into serialisation capabilities in 2016, the company will offer compliant products to all markets, including Europe and the US, from its sites in Newcastle and Swindon, the company announced in a press release.
Wasdell’s new facility in Ireland, due to open January 2019, will also offer serialisation for all products.
Daniel Tedham, managing director of Wasdell Manufacturing said: ”Wasdell operate on a global scale making the ability to comply with regulations of various markets essential, so we made the choice to invest in our serialisation capabilities very early on.”
”As a CMO we handle a huge variety of products that all have specific needs, as well as a customer base of over 250 unique customer who also have their own requirements. It was important that our solution meant we could remain flexible enough to meet these critereon, hence our proactive approach.
Tedham said that implementing a solution across multiple lines that need to supply to numerous markets is a challenging process that many companies have underestimated. He said that Wasdell wanted to ensure it is ahead of schedule to guaruntee that it could effectively support current and future clients with compliance with the EU FMD, US DSCSA and other market regulations.
As part of its serialisation service, Wasdell will also be able to offer three tier aggregation from carton to pallet to ensure compliance with future changes to regulations, it said in a press release.
”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 amends to regulations in other markets.”