The 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 FMD and U.S. 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.

“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 serialization capabilities very early on,” said Daniel Tedham, managing director, Wasdell Manufacturing. “As a contract manufacturing organization (CMO) we handle a huge variety of products that all have specific needs, as well as a customer base of 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 to numerous markets is a challenging process that many companies have underestimated, according to Mr. Tedham. “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, US DSCSA and other market regulations,” he said.

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.

“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.”

For more information about Wasdell’s serialisation service click here.