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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