Service Areas
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
