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 Milton Pharmaceutical Company facility.