We hold a licence with the MHRA allowing us to manufacture, store and distribute a range of Sterile and Non Sterile Investigational Medical Products (IMPs) for Phase I, II, and III clinical trials.
Our products and services include the:
- Manufacture of a range of sterile IMPs e.g. large and small volume injections and nebules and non-sterile IMPs e.g. capsules, encapsulation, creams, ointments, pessaries, suppositories and oral liquids
- Trial specific labelling, over-labelling and re-labelling of partially complete products.
- Bespoke product design and packaging of randomised patient kits.
- The primary and secondary packaging of IMPs of a wide range of dosage forms.
- Investigational Medicinal Product Dossier (IMPD) compilation.
- The provision of technical support, chemical and quality testing for the IMPs produced including ongoing stability testing.
- The batch release and certification of IMPs.
- Support in the admission of applications to the MHRA.
- Storage and distribution to single and multi site storage in the UK, EU and overseas.
Please contact us if you require any additional service or product which is not detailed above.