Regulatory Compliance

AUSTAR's capability in product quality compliance can effectively guide life sciences industry to build an excellent and robust product quality compliance system which ensures competitive product quality.

GxP life cycle development supports product research & development, clinical research, technology transfer, commercial production, distribution, market monitoring, and CRO/CDMO etc., meeting the requirements for GxP compliance and helps life sciences enterprises fully grasp the concept of the quality system and data integrity and the system mode of thinking, lead enterprises grasp the core elements of product life cycle, take root in all-round quality concept including quality culture shaping, quality metrics program setting, data integrity assurance, knowledge management, quality risk management and quality management etc., accomplish continuous improvement and upgrading of the product quality system.

AUSTAR provides clients with compliance solutions for process and manufacturing facility validation & validation testing technology that cover the full life cycle of products. With professional technical capability in design, construction, installation, calibration and maintenance of plants, facilities, systems and equipment required for project construction.

Process and manufacturing facilities validation compliance is based on AUSTAR's understanding of product and technical process to meet clients’demands for design, risk assessment, commissioning, verification, validation, and requalification/re-validation, process validation and continuous validation activities at different stages, helps projects conform to the FDA, EMA, MHRA, PIC/S, NMPA and PMDA GMP and WHO pre-qualification requirements.

Engineering quality compliance service can effectively link engineering quality with product quality compliance. The ability covers the whole process of the project, from feasibility study, demands, design, construction, commissioning & qualification, delivery, operation and continuous improvement and decommissioning. Establishing connection with project management knowledge system, covering good engineering practice tools, methods and standards to ensure compliance.