**7. Preformulation studies: a regulatory perspective**

A preformulation report for a novel molecule includes information on stability, excipient compatibility tests, solid-state characteristics, physicochemical characters, biopharmaceutical features, thermal behaviour, mechanical properties, and analytical profiling. In the area of the IND devoted to CMC/pharmaceutical development, these drug substance features have to be highlighted. For example, the medicine must be in the enantiopure form as it is a legal requirement for IND filing. Therefore, choosing the appropriate drug enantiomeric form should be indicated with its activity before filing an IND or a patent [75].

The characteristics of a specific drug material must now be thoroughly explored early in the initial development process, and the findings from these investigations must be provided in the CMC part of an IND. As part of robust regulatory guidelines, the drug excipient additives, manufacturing procedures, and storage conditions, utilised to make the drug substance and drug product are all included in the CMC section. This data is analysed to make sure that the business can effectively manufacture and supply the drug consistently. Nowadays, regulatory agencies have made a common format of documents for submission as indicated by ICH guidelines to harmonise CMC requirements for global marketing. A common technical document that will harmonise CMC regulatory requirements for global development and marketing. The creation of CMC sections by European Union and American standards yields two formally distinct NDAs. The CMC sections of the EU Marketing Authorization Applications and the US-FDA largely share the same components [33].
