Abstract
The critical importance of communicating with the regulatory authorities on CMC regulatory compliance strategy will be stressed. It also is even more important to listen to what the regulatory reviewers have to say and either follow their guidance or develop a strategy that will address their concern. Assuming that one knows everything that needs to be done in the quest to seek market approval for a biopharmaceutical is neither a scientific nor solid business strategy. In this chapter, senior management is encouraged to engage with the regulatory authorities and take advantage of CMC-focused meetings that are offered.
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Geigert, J. (2019). Invaluable CMC-Focused Meetings with Regulatory Authorities. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_15
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DOI: https://doi.org/10.1007/978-3-030-13754-0_15
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