หน้าที่ความรับผิดชอบ

• Method development, Method Validation, Method Verification
• Stability Study
• Process Validation Analysis and related documents
• Design Study for development (e.g., Compatibility test, Pre-formulation test)
• Prepare dossiers for New drugs, New-generic drugs, and Generic drugs for submission to local and international regulatory authorities (e.g., FDA, ICH)
• Ensure all submissions comply with applicable regulatory requirements and guidelines