We can develop formulations for a wide range of dosage forms, including immediate and controlled release products, powder-in-bottles/capsules and liquids (oral and parenteral).
Our approach is to de-risk the development programme through provision of a logical and well defined formulation strategy with application of Quality by Design principles.
Our advanced materials characterisation suite provides us with a powerful array of tools for solidstate analysis of formulation samples and for problem solving.
We hold an MIA(IMP) licence for the manufacture, testing and certification of products for use in human clinical trials and we have equipment suitable for provision of IMP’s for Phase I and Phase II studies.
Our services include:
- Prototype development and testing
- API characterisation (preformulation)
- Enhanced dissolution screening
- Excipient compatibility screening
- Process development, validation and scale-up batches
- Cleaning method development and validation
- Analytical development and validation (assay / related substances)
- Stability (informal and ICH)
- Methods transfer and cGMP manufacturing for early phase clinical trial supply