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Developing a Regulatory CMC Strategy for Global Markets, with an Emphasis on ICH Guidance
In this podcast, Desi and Ethan discuss the importance of a robust Global CMC regulatory strategy for pharmaceutical companies seeking global market access. It emphasizes the need to understand the regulatory requirements of each target market, harmonize CMC data and documentation across regions, and establish a comprehensive quality system. The article also highlights the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in harmonizing regulatory requirements and supporting a cohesive approach to CMC globally.
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By Despina & Ethan at EnkrisiIn this podcast, Desi and Ethan discuss the importance of a robust Global CMC regulatory strategy for pharmaceutical companies seeking global market access. It emphasizes the need to understand the regulatory requirements of each target market, harmonize CMC data and documentation across regions, and establish a comprehensive quality system. The article also highlights the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in harmonizing regulatory requirements and supporting a cohesive approach to CMC globally.
Support the show