Wasdell Group, an outsourcing partner to companies within the pharmaceutical, medical device and clinical trials industries, has launched its serialization service ahead of the EU Falsified Medicines Directive (FMD) and U.S. Drug Supply Chain Security Act (DSCSA) implementation deadlines.
Following a £2.8 million investment into serialization capabilities in 2016, the company will offer compliant products to all markets, including Europe and the U.S., from its sites in Newcastle and Swindon.
Wasdell’s new facility in Ireland, due to open January 2019, will also offer serialization for all products.
Daniel Tedham, Managing Director of Wasdell Manufacturing, says, “Wasdell operates on a global scale, making the ability to comply with regulations of various markets essential, so we made the choice to invest in our serialization capabilities very early on.
“As a CMO we handle a huge variety of products that all have specific needs, as well as over 250 unique customers 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.
“Implementing a solution across multiple lines that need to supply numerous markets is a challenging process that many companies have underestimated. We wanted to ensure we were ready well ahead of schedule to guaruntee that we could effectively support current and future clients with compliance with the EU FMD, U.S. DSCSA and other market regulations.”
As part of its serialization service, Wasdell will also be able to offer three-tier aggregation from carton to pallet to ensure compliance with future changes to regulations.
The company notes, “Equipping our lines with aggregation capabilities means we are ready to continue supplying products to the U.S. 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.”