It is an electronic tool that allows the MAH to identify the risks presented to the quality, safety and function of each excipient in a systematic and structured approach. SMARTRISK follows the same elements to be addressed as the EudraLex guideline from 2015. This ensures that when addressed correctly the company’s excipient risk assessment meets the requirements of the European regulators. It gives a clear overview of what excipients are present in the various formulations and their associated risk relevant to the individual formulation.