Preclinical Development

Formulation Research & Development (CMC)

A broad portfolio of CMC services spans drug product development, analysis, and clinical trial material supply.

  • Business Scope
    • Formulation development (various formulation technologies platforms, low- solubility product platform, semi-solid platform)
    • Finished product quality research (NMPA-FDA )
    • CTM (various formulation technologies, multiple production lines)
    • Stability studies (compliance with different zones)
    • Regulatory submissions

  • Areas
    • Oral solid (tablet/hard capsule/soft capsule)
    • Injection (aqueous solution/organic solvent)
    • Lyophilization powder for injection
    • Eye drops
    • Semi-solid (cream/ointment/gel)
    • Oral liquid
    • Poor solubility product

  • Project Experience
    • The FDA/NMPA experience:
      Dosage forms include oral solid preparations,
      Injection, biological peptide small molecule, etc.
    • The FDA/NMPA/EU experience:
      Including oral solid preparation, injection, eye drops and topical administration product
    • FDA/NMPA/EU/JP clinical sample production, analytical method development and stability study services

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