With in-depth understanding and interpretation of the requirements of Compilation of Global Data Integrity and Regulations Guidance, AUSTAR provides clients with appropriate compliance application solutions covering the field of human drugs, animal health care, medical instruments combination, medical devices, packaging materials, cosmetics, dietary supplements and food additives.
Focus on pharmaceutical fields - antibodies, cell and gene therapy, ADC coupled drugs, vaccines, blood products, sterile preparations, API, oral preparations and Traditional Chinese Medicine, etc.
Regulatory compliance is the bottom line for the healthy development of pharmaceutical enterprises，operational excellence is the core element to achieve strategic goals. The key purposes of operational excellence is to help enterprises improve their management level, reduce operating costs and enhance their competitiveness in the market and it is a closed-loop management system for enterprises to conduct effective resource allocation and execution tracking in the process of strategy setting and implementation.
Composed of international experts who have successfully implemented operational excellence projects in multinational corporations and achieved excellent performance, AUSTAR operational excellence team is committed to providing pharmaceutical enterprises with process optimization and process improvement based on QbD (quality by design) concept, improving equipment operation efficiency based on lean production theory and comprehensive maintenance services. Six sigma management & improvement methods to improve project guidance capability.