Wasdell Group announces regulatory milestone

Published: 31-Jan-2019

Health Products Regulatory Authority licence has been granted to the company's EU headquarters in Ireland

The Wasdell Group (Wasdell), an outsourcing partner for companies in the pharmaceutical and clinical trials industries, has been granted its Health Products Regulatory Authority (HPRA) licence for its new EU headquarters in Dundalk, Ireland.

Following a successful HPRA inspection in December 2018, the company is now certified to conduct Qualified Person (QP) batch certification and release of pharmaceutical products to Europe ahead of the facility commencing operations in Spring 2019.

Colin Newbould, Director of Regulatory Affairs and QP services at The Wasdell Group, said: “Being accredited with this licence ahead of schedule is testament to our team.

“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).

“Receiving the HPRA licence is an important milestone, bringing us closer to finalising what has been a huge project for us. And, with the 29th March Brexit deadline just around the corner, it means our customers can be confident that we can manage any risk associated no matter the outcome.”

The €30m investment into the Ireland facility was made in 2018 and forms part of the company’s ongoing plans to expand its offering outside of the UK.

The Dundalk facility will offer a full range of contract services including quality control (QC) import testing and batch release for pharmaceutical products, as well as a variety of current and novel packaging technologies. It will also house the company’s largest storage and distribution facilities to date.

Vincent Dunne, CEO of The Wasdell Group said: “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 Irish facility comes as the latest phase in the company’s strategic plan to bolster capabilities and capacity, following the recent £500K investment into its new microbiological and analytical laboratory at its Newcastle, UK site.

Wasdell has also launched a recruitment drive for the Ireland facility, with jobs available across senior management, operations, quality, technical, commercial, financial, warehousing, laboratory and production.

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