Wasdell Group granted IMP licence for European headquarters1 Jun 2020
The licence will allow the company to perform EU clinical release for its European customers and drug developers.
The Wasdell Group, a pharmaceutical outsourcing partner, 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. The company's facilities in Swindon and Newcastle, UK already have an IMP licence.
Colin Newbould, head of quality and regulatory affairs at Wasdell, said: “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."
The Wasdell Group commenced operations at the 100,000 sq. ft 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."
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.
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