Wasdell Group granted HPRA licence at new EU headquarters
The new Irish facility will allow the company to continue to act as a gateway to Europe for its British and North American customers.
The Wasdell Group 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 - an outsourcing partner for companies in the pharmaceutical and clinical trials industries - 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 €30-million 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.
Related News
-
News Pharmaceutical Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain.
-
News Merck KGaA to buy US biotech SpringWorks for US$3.9 billion
The German multinational pharmaceutical company Merck KGaA have signed a deal to buy US biotech company SpringWorks Therapeutics at an equity value of US$3.9 billion in a move to add rare cancer therapeutics to their pipelines.
-
News Cassava Sciences halts Alzheimer's drug trial after limited progress
Cassava Sciences have drawn a close to their investigations and development of the drug simufilam, which they intended to be used for the treatment of Alzheimer’s disease.
-
News US FDA adds haemodialysis bloodlines to devices shortage list
On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines.
-
News Vertex Pharmaceuticals stock jumps as FDA approves non-opioid painkiller
UK-based Vertex Pharmaceuticals saw their stock shares soar as the US FDA signed off on the non-opioid painkiller Journavx, also known as suzetrigine, for patients with moderate to severe acute pain, caused by surgery, accidents, or injuries.
-
News Lessons from CPHI Milan 2024: Sunny Intervals for Pharma Manufacturing?
As the 2024 CPHI conference wrapped up in Milan, we caught up with L.E.K. Consulting – a global strategy consulting firm with deep expertise in pharma manufacturing – to discuss evolving market perspectives and business outlook. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement.