1.QbD Based R&D and Clinical Study Quality System Consultancy Services
Establishing quality management systems in compliance with research and development lab requirements and GLP and GCP requirements based on QbD concepts, establishing complete organization structures and documentation systems pertinent to the research and development phase, to ensure that the assurance system is real and compliant.
2.Technology Transfer Management Consultancy Services
The series of planned and controlled activities for the transfer of the production process, the analytical methods or any other steps and processes related to the drug life cycle from the transferor to the transferee, including from a research and development organization to a manufacturing organization or from one factory to another factory, to achieve the highly efficient and successful technology transfer between the two parties.
3.ICH Q10 Based Pharmaceutical Quality System Consultancy Services
Developing the pharmaceutical quality system documentation for pharmaceutical enterprises based on the ICH Q10 pharmaceutical quality system model, performing the gap analysis and the GMP mock inspections for pharmaceutical enterprises against CFDA, FDA, EU, PIC/S and WHO regulations and guidance, providing the backup supports to the official GMP certification inspections, and helping the continuous improvement of the quality system for pharmaceutical enterprises.
4.Commissioning and Verification Technical Services
Developing commissioning and qualification services in compliance with CFDA, FDA, EU, PIC/S and WHO standards based on science and risk concepts and the life cycle approach, including facility and equipment risk assessment, commissioning and qualification, process validation, cleaning validation, packaging validation and transportation verification, as well as re-qualification/revalidation and the validation activities for facility relocation projects and legacy systems.
5.Intelligent System Planning Technical Services
Providing systematic solution consultancy and execution services utilizing such advanced technologies as information technology, big data and cloud, for the entire drug manufacturing process starting from raw material procurement, production to warehousing and transportation, as well as QA and QC, and developing high efficiency and high quality intelligent system planning technological services pertinent to the characteristics of the pharmaceutical industry and in compliance with GMP requirements.
6.Lean Production Consultancy Services
Developing optimal operation organizations and stable operation systems for our clients in the pharmaceutical industry, using different tools and methods to make our clients' operations scientific, so as to continuously improve our clients' operation performances and continuously improve the operation maturity.