The Health Products Regulatory Authority (HPRA) in December 2018 inspected the Dundalk, Ireland-based facility and has since certified the company to conduct Qualified Person (QP) batch certification and release of pharmaceutical products to Europe.
The facility – following a €30m ($34m) investment in 2018 – is expected to commence operations in spring 2019, ahead of which the company is launching a recruitment drive for several positions.
A range of services will be offered at the facility, including QP release, analytical testing, and distribution services.
Colin Newbould, director of regulatory affairs and QP services at Wasdell called the Dundalk facility an integral part of the company’s “proactive contingency plan” to secure the supply chain ahead of the UK’s exit from the European Union (EU) on March 29, 2019.
CEO Vincent Dunne said in a press release: “With almost 75% of our turnover being a result of export business and a growing customer base in both the Irish and US markets, Dundalk was a logical choice for our EU headquarters.
“The new facility will allow us to continue to act as a gateway to Europe for our British and North American customers.”
The company last year also invested £500K ($651.9K) into its new microbiological and analytical laboratory at its Newcastle, UK site.