We are extensively involved in the development of early clinical formulations and clinical manufacturing of First in Man trials, and can develop a formulation specifically designed to achieve your targets during the crucial first clinical evaluations of your API, then provide clinical supplies of the formulation in the most appropriate form. This is likely to be either a simple powder-in-capsule dose or powder in a bottle ready for reconstitution prior to dosing.
The Well-Proven Early-Stage Manufacturing Technologies We Offer Include:
- Xcelolab system to fill neat API into bottles or capsules ready for Phase I trials.
- Providing the formulated drug in a bottle, in a form designed to offer improved reconstitution and solubility.
For these or any other system you require, we will provide all of the analytical, pre-formulation and formulation data necessary for your clinical trial. Our aim is to rapidly and cost-effectively supply you with a product that maximises the chances of the early clinical evaluation being successful, and provide you with all the information and data required for your IMPD submission.
To find out more about our Fast Track into Man programmes and learn how we could take your API to clinical trials in as little as 16 weeks, please contact us