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Quality Assurance and Regulatory Affairs

Sundia has built up a FDA cGMP complied quality system to assure the quality of services and products for our clients. Our Quality assurance (QA) personnel trains our employees intensively and we established hundreds of SOPs guiding our GMP related activities , from raw materials to final products, from laboratory to pilot plant, from operator to chief executive officer. Many clients come to audit our quality systems and facilities for their R & D projects to be conducted in Sundia.

Quality Assurance
• Standard Operating Procedures
• Training management
• Good Documentation Practice
• Archive management
• Material management
• Specification management
• Vendor qualification and contract manufacturer qualification
• Calibration and maintenance
• Quality incident management, including deviation, OOS, customer complaint, and product recall
• Change control
• Validation and qualification management
• Package and label management
• Internal audit and routine inspection

Regulatory Affairs
• Regulatory and strategic consultation for early development stage of new drug
• Compiling of registration materials, including reviews, CMC, Pharmacological and toxicological data and clinical research protocol
• Preparation of registration documentary
• Submission of registration materials, coordinating and preparing for the On-site inspection
• Compiling Drug Master File (DMF)

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