This license 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 license.
“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,” said Colin Newbould, head of quality and regulatory affairs at Wasdell. “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.”
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 facility also offers high bay warehousing and is approved for ambient, chilled, temperature-controlled and humidity-monitored storage and distribution.
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.