CMC Package including analytical services and Stability studies

• One-stop services with high quality and fast turn-around time
• Strong experience and regulation knowledge contribution to IND, NDA and ANDA projects

CGMP COMPLIANT METHOD DEVELOPMENT/VALIDATION AND QUALITY STUDIES

• Method development and validation for starting materials, intermediates, and APIs
• Method development and validation for drug product
• Testing and release of APIs and drug products
• Supportive tests for process studies and manufacture
• Identification of impurities and structure elucidation and confirmation
• Chemical/physical characterization of APIs
• Qualification of reference standards

STABILITY STUDIES ACCORDING ICH/FDA/CFDA GUIDELINES

• Dedicated stability manager and facilities. Calibrated stability chamber equipped with auto-alarm and backup power systems
• Stability studies include preparation and approval of stability protocols, sample management, sample testing, data and trend analysis and preparation of reports
• Stability indicating method validation and transfer
• Stability conditions include:

  -20°C

  5°C

  25°C/60%RH

  30°C/65%RH

  30°C/60%RH

  40°C/75%RH

  50°C

  Photostability

REGULATORY CMC DOSSIER PREPARATION FOR CHINA AND GLOBAL SUBMISSION