Outsourcing partner for the pharmaceutical industry, The Wasdell Group (Wasdell), has announced that its new state-of-the-art facility in Dundalk, Ireland has received its Manufacturer’s / Importation Authorisation licence (MIA) from the Health Products Regulatory Authority (HPRA).
The new EU headquarters, which are a result of a significant investment in a greenfield site at the new IDA Technology & Science Park, Dundalk, has now commenced operations.
The 90,000 sq. ft. facility houses 11 bespoke production suites and temperature controlled high-way warehouses increases Wasdell’s capacity in clinical and commercial packaging, distribution & logistics and QP services.
With building work commencing in September 2018, the facility is thought to be the fastest custom-built site to achieve cGMP approval.
Wasdell also has facilities in Swindon, Northampton and Newcastle, UK, and has grown to be an industry leader by offering flexible and agile solutions to its growing customer base.
The Ireland site will support the company’s ongoing growth, whilst also allowing Wasdell to cement its presence in Europe in preparation for Brexit.
The site also underwent a successful HPRA inspection in late 2018, which granted permission to perform QP batch certification and release of pharmaceutical products into Europe, further supporting Wasdell’s Brexit preparations.
Vincent Dunne, Wasdell’s CEO, said: “This is another significant milestone for Wasdell, and I am extremely proud of our team and the efforts made to open this facility.
“We are seeing growing demand for our services, especially from companies that wish to outsource their entire product lifecycle from clinical services and EU launch to manufacturing, packaging and distribution. The new facility strengthens our offering, allowing us to further support our customers.
“With over 75% of our turnover as export business, our new facility will serve our large client base in Europe and better support our growing US customer portfolio as they look to outsource their European supply chain operations from clinical projects to routine supply.”
“We have onboarded an experienced team who are well-versed in overseeing rigorous quality standards and ensuring operational efficiency to improve customer experience and enable our promise to deliver safe, high quality products to patients in Europe.”