Service Advantages

As a professional quality assurance team, familiar with ICHGCP and relevant international regulations, familiar with NMPA's drug and device GCP and related regulations. Using inspection as a problem discovery tool and CAPA platform management as a trend analysis tool, we aim to continuously improve the quality of clinical research. As the manager of NMPA on-site inspections, ensure the smooth passage of on-site inspections.

A sound quality management system

● Standard operating procedures and template libraries with international standards developed based on ICHGCP and CRO experience;

● After nearly 20 years of domestic and international inspections/verifications, the quality system has been continuously updated and improved;

● Timely revise the quality system in accordance with regulatory changes to ensure timely compliance of all operations.

Service Scope

● Quality system construction; Drugs, medical devices, computer systems, IRC, PV operations, central laboratories, etc.

● Internal quality system inspection, TMF inspection, project research center inspection, comprehensive inspection of data integration projects, CSR inspection;

● Supplier inspection, including inspection of central laboratories, EDC products, random systems, PV systems, GMP drug packaging, transportation companies, etc;

● Independently from the operations department, the QA team undertakes third-party inspections commissioned by the applicant and is able to issue inspection reports in Chinese, Japanese, and English languages.

● Provide on-site inspection preparation, on-site inspection management, and response services for inspection issues.

Targeted Training

● Provide targeted training on the analysis and summary of inspection findings;

● A standardized training course library covering over 600 courses and a comprehensive personnel training system; Including basic knowledge training, quality system training, project level training, and employee skills training;

● Supervise employees to learn and develop, with the goal of independent work and collaborative development.