Phase 1 Clinical Manufacturing Services
We are extensively involved in developing early clinical formulations and clinical manufacturing of First in Human trials. We can develop a formulation specifically designed to achieve your targets during the crucial first clinical evaluations of your API.
We will provide the formulation’s clinical supplies 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, preformulation, and formulation data necessary for your clinical trial.
We aim 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.
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