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Requirement of Biowaiver for Sterile Dosage form in BRAZIL

  • 1.  Requirement of Biowaiver for Sterile Dosage form in BRAZIL

    Posted 21-Jan-2023 07:28
    Hi All,

    Can you someone guide to share requirement of Biowaiver for Sterile Dosage form for submission to ANVISA?
    Is there any RDC for requirement for submission of Sterile Dosage form dossier to ANVISA?

    Regards,
    Urvish Shah

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    Urvish Shah
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