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Resource Center 中文

Regulatory compliance and operation excellence is based on scientific pharmaceutical philosophy and comprehensive risk analysis method. Through professional technical consulting services on regulatory compliance and operation excellence, AUSTAR helps customers improve their overall competitive advantages and win future development opportunities.With collection of high-quality technical resources of the global pharmaceutical industry and through in-depth cooperation with more than 30 world-renowned members of the technical steering committee and subject experts, AUSTAR ensures to provide authoritative technical compliance guidance for clients on the basis of correct understanding of the industry development direction and trend. Based on the deep understanding of the regulations and processes of the pharmaceutical industry and the real-time follow-up of the regulatory guidelines of the global Drug Regulatory Authorities, AUSTAR can bring cutting-edge interpretation of the regulatory guidelines to the clients and conduct efficient transformation and implementation according to the clients' situation. The largest professional project execution team in Asia which consists of over 200 senior project managers and professional engineers and the experience of serving more than 500 abroad & domestic enterprises with excellent quality projects guarantees AUSTAR's efficient and high-quality project execution capability.The Group participated in setting the national standard GB51069-2014 titled "Technical Code for Traditional Chinese Medicine Production Plant Engineering" and published technical monographs such as "Pharmaceutical Process Validation & Implementation Manual" and "Compilation of EU GMP/GDP Regulations" and Data Sets such as "ASTM E2500 Application Guide”, "Compilation of EU GMP Regulations" and "Compilation of Global Data Integrity Regulations Guidance" for the purpose of helping clients use scientific approaches to control risk and improve the compliance capability and operational excellence.

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Regulatory Compliance

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.

Operational Excellence

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.