Quay Pharma operate from two sites around 15km apart, one in England and the other, our head office Quay House, in North Wales. Both are in easy reach of Liverpool and Manchester Airports. Quay House is a 40,000 square foot facility with superb laboratory facilities near Chester, and since we moved there in 2010 it has been the home of all of our activities, except manufacture, which is located at our sister site in Bromborough. At the beginning of 2014 Quay Pharma revealed plans to invest £3 million to build a new 6 room manufacturing suite at its site in Deeside. With the investment now being a fully validated MHRA approved facility, manufacture is now conducted within head office, Deeside.
Our clinical manufacturing areas all meet the standards set out in the Good Manufacturing Practices criteria, and have been audited and accredited by the Medicines and Healthcare Products Regulatory Agency (MHRA). We also hold a Manufacturing Authorisation for the manufacture and testing of Investigational Medicinal Products (IMPs), including medical devices, as specified by the EU Clinical Trials Directive (2001/20/EC).
Significantly, we are also one of the small number of companies licensed by the MHRA to carry out Specials Manufacture. Specials are unlicensed medical products produced to meet the particular clinical requirements of individual patients whose needs cannot be met by licensed medicines.
We have the capacity and necessary licences to handle controlled drugs and, because we supply a large volume of clinical trial products to North America, we are registered with the FDA following a successful establishment inspection of the Quay Pharma facility.