Certificates

To uphold the pharmaceutical-grade standards of quality control, GWOXI implements rigorous safeguards throughout the entire process, from production to transportation:

1. Clinical-grade cell bank aligned with the electronic Common Technical Document (eCTD)

2. Our production process adheres to international standards, with quality maintained through national certifications. Our products have been honored with domestic and international awards.

1. In 2013, GWOXI was certified with ISO9001 and has since implemented its three major quality policies: “Innovation, Excellence, and Responsibility.” To maintain internal quality, our manufacturing processes and technical services have consecutively received the SNQ certificate under the category of Biotechnology and Medicine Industry. We are committed to continuously improving product quality to ensure all products meet customer expectations.
2. In 2013, GTESTing®, an independent testing lab derived from GWOXI, was certified under ISO/IEC 17025:2005. This certification ensures that the quality of its analysis for all stem cell therapy products and its external commissioned testing services meet international standards.
3. In compliance with international standards, the products developed by GWOXI are actively submitted for domestic and international awards each year. Over the past decade, four stem cell medicines have been recognized with accolades such as the Pharmaceutical Technology & Research Development Award (PTRD), Taipei Biotech Awards, National Innovation Award, and Hsinchu Science Park – Innovative Product Award. GWOXI has also participated in the Hsinchu County Government Local SBIR Project. These achievements reflect the principles of our quality policy.

3. Rigorous monitoring of the cell product transportation process through our internal cold chain control model.

Certifications

Superlab Proficiency Testing

Symbol of National Quality

Taiwan Accreditation Foundation