IND CMC Documentation for new novel drug candidates

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In order to be able to carry out human studies using new drug candidates, it is necessary to file an application with the appropriate regulatory authorities. In the US this is referred to as an Investigational New Drug application. There are similar applications in other countries, but have different names and require slightly different formats.

Much of the data in the initial application will concern the pharmacology and safety of the new drug candidate. However, information is also needed on the synthesis and stability of the API and the manufacture and stability of the formulation to be used in the clinical trials, usually referred to as the Chemistry, Manufacturing and Controls (CMC) section of the IND.

FinnBrit consulting can advise on how best to prepare the CMC sections of INDs.

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