DETAILS DESCRIPTION
Analytical R&D
- Position :
Our analytical chemistry team provides comprehensive analytical testing support for process development and drug substance and drug product manufacturing. Our analytical team follows regulatory guidance on supply chain assurance for quality control. The analytical capabilities include platforms of excellence for the following:
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
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