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    RE: MDSAP

    By: Ivan Whelan , 4 hours ago
    Posted in: Regulatory Open Forum

    Hi Maria with regards to your AO request drop me an email might have something done that would help the specific checklist specifies the nuances for each jurisdiction for product being sold to in line with both the regulatory and companion document stated links etc  Kind regards, ------------------------------ Ivan Whelan Director mobile: +447453318474 ...

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    Studying for RAC (Global) Exam

    By: Ai Khim Ang , 6 hours ago
    Posted in: Regulatory Open Forum

    How does each domain in RAC (Global) checklist correlate to the chapters in the textbook? Sent from Yahoo Mail on Android

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    Comparison Studies for Generic Injectable

    By: Xueling Shen , 15 hours ago
    Posted in: Regulatory Open Forum

    For a Generic Injectable submission using DCP in EU, does the manufacturer have to purchase Reference product from the RMS and conduct some sort of comparison studies on Physical chemical in order to generate some data for ? Assume the formulation is same and no clinical study is required.

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