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Clinical Phase

Depending upon the type of generic product you are developing, you may need to conduct clinical trials in order to demonstrate bioequivalence to the originator's product. This will be an important phase for you as for the first time you will be seeing how your product behaves in humans.

Alternatively, the profile of your product maybe such that you can avoid having to conduct such studies by applying for a Biopharmaceutical Classification (BCS)-based biowaver. Whichever approach is taken, it is more important than ever that you work with real experts at this critical time.

We will champion your product and remain dedicated to the project until your medicine has reached the market and is benefiting patients.

Have you an established working relationship with a quality CRO experienced in Phase 1 studies?

Are you experienced in preparing CTAs?

Do you need advice on how to optimise your study protocol (e.g. use of parallel, sequential or steady-state design)?