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Preparing the Quality Overall Summary in the New Paradigm

Preparing the Quality Overall Summary in the New Paradigm. Michelle Herrera Foster, Ph.D. Regulatory Affairs Consultant CTD Quality Consulting. Topics. What is a Quality Overall Summary (QOS) Regulatory Evolution The New CMC Paradigm QOS as a Key Reviewer Tool QOS Pitfalls QOS Keys

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Preparing the Quality Overall Summary in the New Paradigm