Total CMC Services by Expert Biologists

Fast, Efficient, High-Quality Services

Business content

  • Document Preparation

    • Drug Quality Consultations; Ad Hoc Consultations
    • Pre-Assessment Quality Consultations
    • Pre-Phase 1 study Quality-related Consultations
    • Supporting Documents for Clinical Trial Notification
    • JAN Applications
    • Foreign Manufacturer Accreditations
    • GMP Inspection Applications
    • New Drug Application Forms and CTD
    • Master File Registration Applications
  • Consulting

    • Quality-related Regulatory strategy planning
    • CMC assessment advice / due diligence
    • GMP compliance support
    • Advice on quality consultation with authority
  • Translation

    • Translation service by specialists in biology/CMC
    • Support on CMC-related communications with overseas clients’ headquarters

Our Activities

  • We provide CMC services in the areas of biological drugs (antibody drugs, vaccines, recombinant products, biosimilars), synthetic drugs, and generics,among others.
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