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Add:9 Hui Xin Xi Jie, Hui Xin Yuan #4 TengDa Office Building, Room 3307 Beijing 100029, P. R. China
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Foreign submission

Support submission to US FDA, CE Mark, TGA and Competent Authorities in other Asian countries
With very broad knowledge and long-term working partnership worldwide, BioHan Consulting is able to support the pre-market approvals in the major markets outside of China for the products manufactured in China. Our expertise include:
  • Preparing submission dossier
  • Conducting China vendor ISO13485 or GMP audit, and attendance in external audit
  • Reviewing risk management report according to ISO 14971;
  • Managing type testing to be done by a Chinese test house internationally recognized or ILAC accredited
  • Assisting with clinical trial protocol, ethic approval, and implementing clinical trial project and data collection, as well as managing relation with clinical centers in China


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Add:9 Hui Xin Xi Jie,Hui Xin Yuan #4 TengDa Office Building, Room 3307 Beijing 100029, P. R. China
Tel:(8610)64813589    Email:inquiry@biohanconsulting.com
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