1. Formulation 2. Pre-clinical 3. Clinical Trials 4. Registration
This stage involves registering a medicine or medical device with local regulatory authorities so they can be distributed within that region.
As much as possible we optimise our development plan before we start in terms of things like patient sample sizes and end-points that the regulator will require. We actively identify risks for the regulator and show them our risk mitigation strategies. This can be quite an exhaustive process, but the first customer you have to satisfy is the regulator.
Because we’re not a large multi-national pharmaceutical company, and we have to ensure we spend our R&D budget wisely, we absolutely have to get the process right. And we do.