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BioHan Consulting
Tel: (8610)64813589
Fax:(8610)64813589
Cell:13501126282 Email:inquiry@biohan
consulting.com
Add:9 Hui Xin Xi Jie, Hui Xin Yuan #4 TengDa Office Building, Room 3307 Beijing 100029, P. R. China
BioHan Consulting
Tel: (8610)64813589
Fax:(8610)64813589
Cell:13501126282 Email:inquiry@biohan
consulting.com
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:
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
Links：qq | baidu | China Food & Drug Administration |
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
Links：qq | baidu | China Food & Drug Administration |