Quality Policy
Committed to innovative and high-quality manufacturing and management, ensuring customer satisfaction, and providing safe and effective medication to patients
Advantages
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The quality system establishment and plant design & construction are based on NMPA, FDA, PIC/S, and EMA regulatory requirements,
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which have continually completed multiple rigorous rounds of regulatory agency, consultants GMP compliance inspections
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BioDlink (TOT BIOPHARM) established a high-level effective pharmaceutical GMP quality systems and implemented for clients, to provide reliable services for successful regulatory submission. Together with clients to achieve milestone of projects, and ensure stable and reliable development pipeline of biological product
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Bilingual quality management system to ensure the product manufacturing quality, compliance, and medication safety for patients.
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Experienced, comprehensive, electronic systematic management, and regular backup management system to ensure data integrity, authenticity and traceability
Quality Assurance
ICH Q8,Q9 and Q10 Pharmaceutical Quality System Lifecycle Management
Quality Management System (QMS)
Drug product Lifecycle Management