• Business Areas

    Generic Drug Consistency Evaluation (BE)

    Service scope
    Bioequivalence studiesBioequivalence studies
    Regulatory Affairs

    High quality, one-stop service for BE studies/generic drugs quality consistency evaluation

    To support generic drug companies, Tigermed offers a professional BE clinical operation team that hasa strong technical background and expertise in this specific area. Their unparalleled capability ensuresa science-based approach and a pragmatic protocol design according to best practices and emerging scientific practices globally. With its extensive experience in analytical method development in a broad variety of chemical compounds, they have a proven track record of meeting and exceeding client expectations.

    Having the largest phase I clinical center resource in the eastern US,and over 18clinical sites which are set up with professional hospitals offer a modern and reliable quality assurance system that is implemented in our labs both in China and comply with the FDA (US), NMPA (China), and EU GCP standards.
    Our unified quality system is implemented in our labs both in US and China and our routine operations successfully passed over 50 FDA and 80 NMPAsite inspections.

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