Pharmaceutical outsourcing partner, the Wasdell Group, has been granted an Investigational Medicinal Product (IMP) licence by the Health Products Regulatory Authority (HPRA) at its Dundalk, Ireland facility.
This licence enables Wasdell to expand the facility's services to include clinical importation and distribution. Wasdell's facilities in Swindon and Newcastle, UK already have an IMP licence.
Colin Newbould, head of quality and regulatory affairs at Wasdell, said: "This is a great achievement for our Dundalk facility and testament to our excellent team."
Newbould added: "The licence is particularly important for our EU hub in Dundalk as it allows us to perform EU clinical release for both our European customers and drug developers in the UK, US and other countries outside of the union."
"Offering that stepping-stone and navigating the complexities of the market are key reasons our commercial customers rely on Wasdell time after time, and we are thrilled to be able to offer this gateway for clinical trials now too," Newbould added.
The Wasdell Group commenced operations at the 100,000 sqft Dundalk facility in June 2019, offering a broad spectrum of flexible packaging solutions for the life science industry.
The Dundalk facility also offers high bay warehousing and is approved for ambient, chilled, temperature-controlled and humidity-monitored storage and distribution.
Vincent Dunne, CEO, added: "Our new Dundalk capabilities will complement the services offered by Wasdell UK and further strengthen capabilities for EU supply."
"We have the ability to accommodate all trial requirements (open, double-blinded) and phases, and we can design multi-language labels for all European languages," Dunne said.
This news follows the company's multi-million-pound investment in equipment to bolster the Group's blister and bottle lines, vial labelling, stability chambers and cold storage capacity.
The Wasdell Group offers end-to-end services across manufacturing, packaging and storage and distribution.