API development is the core of drug development for any pharmaceutical. At TBD, we work with both generic and innovative molecules.
If it’s a generic API hitting the market in a few years, after patent protection is over, we’ll firstly study the literature, run the feasibility studies (and share the results with you), develop the actual processes, and upscale the technology to the necessary level. Parallely, we’ll develop all the quality control methods for your API, starting materials, and intermediates.
We’ll also prepare full GMP documentation, manufacture technical batches (which can already be used for the development of the final drug form), validate the GMP process, and deliver validation batches. You’ll receive ASMF as well as full support from our regulatory specialists.
On the other hand, if it’s an innovative molecule entering clinical studies, we can assist you with all the chemistry services. First, we’ll run the route scouting—or, if you already have developed the route, we can take over and optimise it—and then, after the process is developed and the toxicity batch is prepared, you get to choose: Manufacture the first GMP batch for clinical studies or go for full scale process validation.
Either way, we’ll provide you with the full CMC documentation.