Expert article: Streamlining small molecule API development and regulatory compliance


The end goal of API innovators is to develop an API that will succeed in clinical trials. Many steps and processes are considered in formulation and development that would enable an API to successfully transition to the clinic. Achieving regulatory compliance is critical at each phase of the API journey. Read our expert discussion of the key challenges meeting regulatory requirements at each phase of development, recommendations for overcoming these challenges, and how partnering with a trusted CDMO can make a significant difference in the journey.