Clinical Trial Manufacturing
With a flexible and personalised approach, we can manufacture important batches of drug product and placebo-to-match for Phase I, Phase II and Phase III clinical trials, supporting this crucial stage of new medicine development and patient therapy.
- Tailored formulation development for your preferred dosage form, including tablets, capsules and powder for oral solution.
- A strategy that recognises the specific requirements of your clinical trial can be adopted
- Placebo-to-match active product for blinded trials
- Bespoke tooling sourced to match round or shaped, debossed or plain tablets
- Film-coated tablets
- Hard gel capsules
- Precision powder dosing of drug into hard gel capsules, to as low as 1mg per capsule
- Dedicated Pilot Plant for small-scale clinical product development and manufacture, with options for scale up to larger batch sizes
- cGMP manufacture, testing and supply of Investigational Medicinal Products (IMP) in bulk to third party clinical trial packaging sites
- MIA(IMP) QP certification
- Creation and Maintenance of the Product Specification File relevant to the manufacture of the bulk product at CPS.
- Resupply of product where required to support ongoing trials and future demand