Abstract
The critical importance of communicating with the regulatory authorities on the CMC regulatory compliance strategy will be stressed. In addition, the critical importance of listening and following their guidance will be examined. Finally, in this chapter, an encouragement is given to senior management to take advantage of CMC-focused meetings available with the regulatory authorities.
We know how to do it better than the regulatory authorities, so why involve them and muddy the waters?
Frequent comment from senior management, heard by this author
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Geigert, J. (2013). CMC-Focused Regulatory Meetings. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6916-2_13
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DOI: https://doi.org/10.1007/978-1-4614-6916-2_13
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