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The Wasdell Group has been granted a Health Products Regulatory Authority (HPRA) license for its new European headquarters, based in Dundalk, Ireland.
Outsourcing partner for companies in the pharma and clinical trials industries, The Wasdell Group, has been granted a Health Products Regulatory Authority (HPRA) license for its new European headquarters, based in Dundalk, Ireland.
The HPRA license was approved following an inspection of the Dundalk facility in December 2018 and will allow the company to perform Qualified Person batch certification and release of pharmaceutical products into Europe. These QP services will add to the other contract services the company will offer from its HQ when it begins operations in spring 2019, such as quality control (QC) import testing and batch release for pharmaceutical products, as well as a variety of current and novel packaging technologies.
“While this expansion will allow us to cater for increased customer demand, the Dundalk facility is also an integral part of our proactive contingency plan to protect our customers critical supply chains ahead of the UK’s exit from the European Union (EU),” said Colin Newbould, director of Regulatory Affairs and QP services at The Wasdell Group. “Receiving the HPRA license is an important milestone, bringing us closer to finalizing what has been a huge project for us. And, with the Mar. 29, 2019 Brexit deadline just around the corner, it means our customers can be confident that we can manage any risk associated no matter the outcome.”
“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,” added Vincent Dunne, CEO of The Wasdell Group. “The new facility will allow us to continue to act as a gateway to Europe for our British and North American customers.”
Source: The Wasdell Group