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Invaluable CMC-Focused Meetings with Regulatory Authorities

  • John Geigert
Chapter

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.

Keywords

Communication CMC strategy EOP2 meeting Pre-submission meeting Scientific advice 

References

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

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