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Regulations

  • October 14, 2021

    Question and Answer: Stability Testing Study Design and Data Evaluation

  • August 23, 2021

    In-Use Stability Studies for Multi-Dose Products (Part 2: Other WW Authorities)

  • August 10, 2021

    In-Use Stability Studies for Multi-Dose Products (Part 1: EMA)

  • June 9, 2021

    ANVISA’s Guidance on Forced Degradation Studies Explained – Part 3

  • May 6, 2021

    ANVISA’s Guidance on Forced Degradation Studies Explained – Part 2

  • April 21, 2021

    ANVISA’s Guidance on Forced Degradation Studies Explained

  • March 15, 2021

    Stability Testing Study Design and Data Evaluation to Support a Clinical Study in the European Union: Part 2

  • February 28, 2021

    Stability Testing Study Design and Data Evaluation to Support a Clinical Study in the European Union: Part 1

  • June 13, 2020

    Virtual / Remote Inspections – The New Normal?

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