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Rimsys 2024 RegEx AMA
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Quality Overall Summary(QAS)

  • 1.  Quality Overall Summary(QAS)

    Posted 05-May-2022 10:59
    Hello All,
    Technically how many QOS should be there under drug substance and drug product, if it is more than one how should it be present in an Application?
    Is there any recommendation for the reviewer's perspective for their easy review and not making cumbersome of documents, on how to present QAS if it is more then one drug substance or if it is combination drug,

    Thanks In Advance for your suggetsion

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    Pallavi Sharma
    Florham Park NJ
    United States
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