S. Connor Dennis, PhD

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Pfizer
CMC Regulatory Consultant
S. Connor Dennis, PhD, is a CMC regulatory consultant for Pfizer. He is a research scientist with industry experience in drug product development and global CMC regulatory affairs along with an academic background in bioengineering, materials science, and regenerative medicine. He has spent over six years consulting as a CMC author and strategist, supporting the Pfizer Plant Network Strategy (PNS) group in postapproval CMC changes. In addition, he has served as a data analytics lead on the to assess and improve global regulatory approval forecasting.

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An Evaluation of Postapproval CMC Change Timelines
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An Evaluation of Postapproval CMC Change Timelines

As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC)...