Since moving to Quay House in 2010 Quay has continued to invest in and expand its GMP manufacturing suites at Deeside having a fully MHRA licenced facility which has also been FDA inspected. In September 2020 we expanded our operations in Deeside with the purchase of a second UK laboratory and office facility which will allow Quay to expands its development and analytical services at Newtech Square also on Deeside. Read our press release.
In November 2020 Quay expanded its global footprint by taking on a 55,000 sq ft facility in Hudson, New Hampshire, US. This facility will be completed to support development and GMP manufacturing activities with initial project work starting in May 2021. Read our press release.
We are now recruiting in the US. Click here for more information.
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 to carry out Specials Manufacture. Specials are unlicensed medicinal 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.