• RF Quarterly

    CMC regulatory strategy

    Regulators make benefit-risk decisions based on the three pillars of quality, safety, and efficacy. CMC is applied throughout the product development spectrum from the initial synthesis of a molecule to reach a hypothetical target, to commercial scale up and beyond. This article helps the reader navigate the CMC regulatory landscape and understand the multiple considerations needed in order to devise a strategy which is efficient with respect to cost and time to approval. ...