• Business Areas

    Chemistry, Manufacturing, and Controls (CMC)

    The laboratories are located in Exton, Pennsylvania, US and Suzhou, China and both operate under thesame quality system to ensure effective method transfer and data reporting for regulatory submissions in China and the US. Together, these labs have passed almost30 inspections by FDA (US), NMPA (China) and DEA.

    Services Scope
    Preclinical research/DMPK
    ? Bioanalysis
    ? Pharmacokinetics PK/PE
    ? Bio/immunoassay
    ? Biomarker analysis

    CMC Services
    ? GMP API manufacturing /organic synthesis of reference standards
    ? Pharmaceutical product formulation development
    ? GMP clinical trial material manufacturing (non-sterile and sterile forms)
    ? GMP analytical services including method development and validation

    CMC Laboratory
    ? 31645 square feet of CMC analysis and GMP formulation laboratory space is located in Exton City

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