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Case study

Key CMC Challenges for Innovative Healthcare Products

Post thumbnail Key CMC Challenges for Innovative Healthcare Products

Have you encountered CMC challenges in the development of your innovative healthcare product? CMC includes all activities vital to product approval: product characteristics, manufacturing methods, and product testing – to ensure product safety, efficiency, and standardization. Moreover, innovative products, such as cell therapy, are classified as ATMPs (Advanced Therapy Medicinal Products) by the FDA. Therefore, they often face specific development challenges, because of their complexity and no defined regulatory framework.

Our CMC team of experts collaborated closely with the client to ensure the project stayed on track and overcame key CMC challenges… Find out more by downloading below!


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    Our Expertise

    CMC expertise is critical to successful product development through all stages of the process. This is especially the case for innovative products with no clear regulatory frameworks.