Why is it necessary to choose animal study institution(s) properly?


Pre-clinical animal study is a way to preliminarily verify the safety and efficacy of medical devices before their clinical trials. In NMPA Guidelines for Technical Review of Animal Study of Medical Devices - Principles for Decision-making, guidance suggestions have been given on the circumstances under which it is necessary to carry out animal studies.

In fact, truthful, reliable and accurate results from pre-clinical animal studies are the foundation of quality assurance in laboratory, and the know-hows in quality management of animal studies are essential for quality assurance of animal studies. At present, FDA has issued relevant guidelines for GLP-compliant non-clinical animal studies of medical devices. In China, GLP management has also been implemented in pharmaceutical research, which fundamentally improves drug research level and guarantees drug research quality. However, the implementation of GMP management in non-clinical studies of medical devices is still confronted with a number of challenges, the regulation standardization is still under continual improvement.


图片100% independent professional third-party institution

Shanghai Harborside Medical Technology Co., Ltd. (Harborside) is located in Lingang New Sub-district, China (Shanghai) Free Trade Pilot Zone. Its predecessor is NAMSA Shanghai Lab. Harborside is the first AAALAC-accredited medical device CRO in China. It is a medical device pre-clinical animal study laboratory that has been operated in line with FDA GLP system since its foundation.

Harborside provides services to many renowned Chinese and foreign companies. Many of its pre-clinical safety and efficacy studies have been approved for FDA PMA/510K and NMPA submission.


图片Diligent building of a professional team

Harborside is currently building up a first-class core team and state-of-the-art equipment and a rigorous quality management system for providing the best service to its clients.

 

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