HPRA Grants IMP License to Wasdell Group

May 28, 2020
Pharmaceutical Technology Editors

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

In a May 28, 2020 press release, the company stated that the license will enable an expansion of the Dundalk facility to include clinical importation and distribution. The company’s facilities located in Swindon and Newcastle in the UK already have an IMP license.

“This is a great achievement for our Dundalk facility and testament to our excellent team. 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, in the press release. “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.” 

“Our new Dundalk capabilities will complement the services offered by Wasdell UK and further strengthen capabilities for EU supply,” added Vincent Dunne, CEO of Wasdell, in the press release. “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.”

Source: Wasdell Group