Quay Pharmaceuticals is experienced in providing a comprehensive out-sourcing service for formulation and analytical development with subsequent clinical trials manufacturing for pharmaceutical and biotechnology companies world-wide.
Working as a dedicated, pro-active part of your team we apply strong project management and technical expertise to take products quickly and cost effectively from late stage pre clinical through to the end of phase II clinical trials.
Quay Pharma has vast expertise in dosage form design and development and with Professor Mike Rubinstein (CEO) and Professor John Collett (CSO), Quay Pharma has built a reputation for specialising in the formulation of API’s that exhibit poor solubility and bio-availability and those which require modified or controlled release. This has resulted in many Quay Pharma clients successfully licensing products on to large, global pharmaceutical companies.
From MHRA licensed and FDA registered facilities the company provides;
• pre-clinical to commercial formulation development
• novel drug delivery system design
• analytical – transfer or method development and validation
• ICH stability testing
• clinical trial manufacture in class 100,000 (ISO 8) environment
o conventional, coated and controlled release tablets and capsules
o powder, liquid / semi-solid fill capsules
o liquid /semi solid formulations (e.g. nasal and oral solutions, creams)
o pellets / spheroids and extrudates
o medical devices
• packing and labelling
• full QC testing services
• QP certification and importation of investigational medicinal products from outside the EU.
• CMC’s and regulatory document support for product registration
Quay Pharma holds a Manufacturing Authorisation from the MHRA for the manufacture and testing of investigational medicinal products (IMP’s), as specified by the EU Clinical Trials Directive (2001/20/EC) and also possesses a “Specials” licence.
For further information contact:
European Business Development Manager
Telephone: +44 (0) 1244 837 004