NHS production specialists in Investigational Medicinal Products for Clinical Trials
Newcastle Specials, under its MHRA Manufacturer’s Authorisation – Investigational Medicinal Products Licence, MIA (IMP), is growing a significant reputation for being the go-to provider for drug manufacture for clinical trials.
Newcastle Specials is a technically capable manufacturing unit, able to provide full support and advice to sponsors throughout the life of their clinical trial. Newcastle Specials benefits from being able to manufacture Investigational Medicinal Products in its production unit whilst, through its Quality Control and Quality Assurance Teams, also being able to test the quality of incoming raw materials and the final drug before it is released through a Qualified Person to clinical trial patients. Capability includes:
- IMP manufacture, assembly and packaging
- Over-encapsulation of solid dosage forms for blinded studies
- Label design and printing for open label and randomised blinded studies
- Labelling and assembly of patient kits
- Storage and distribution capabilities
- Post study drug returns, reconciliation and destruction
- Full supply-chain Qualified Person declaration and certification
- Analytical method development and drug stability programmes
- Integrated quality system, including Qualified Person.
If you are planning to undertake a clinical trial and would like more information about our clinical trials service, please contact:
Laura Larrieu, Clinical Trials Pharmacist
email: Newcastle Specials Clinical Trials
Telephone: 0191 282 0395