Kexing Biopharm has been adventuring into the global for 20 years, established a relatively complete overseas business system, and accumulated rich resources and commercialization capacity
OVERSEAS PRODUCT REGISTRATION AND CLINICAL TRIAL
Familiar with the registration regulations of biological preparations in various countries, have rich experience in communication and coordination with foreign drug regulatory registration departments, and accelerate market access
Europe：EMA Biological Products Registration Regulations
Central and South America：Brazil ANVISA, Colombia INVIMA, Peru DIGMIED
Africa：Egypt MOH, Nigeria MOH
Asean：Indonesia BPOM, Philippines MOH
South asia：India DCGI, Pakistan DRAP, Bangladesh MOH
MENA region：Syria MOH, UAE PROMETRIC, Jordan
CIS region：Russia MOH, Ukraine MOH, Uzbekistan, etc.
Overseas markets choose countries with strong regulatory influence to give priority to declaration work;
Familiar with the drug registration regulations of various countries, have rich experience in communication and coordination with foreign drug regulatory registration departments, and accelerate market access;
Rich registration materials preparation and translation.
OVERSEAS DEVELOPMENT AND MARKETING
With more than 20 years of overseas commercialization experience, it has achieved access and sales in more than 40 countries;
The core members of the foreign marketing department have more than 10 years of overseas development and marketing experience;
Separately set up marketing, regulatory, business and other departments, set up 4 branches around the world, and manage 5 major business areas;
Sinovac has gradually built its overseas platform, and has introduced products such as nab-paclitaxel, inflixime, bevacizumab, adalimumab, and liraglutide, and has deployed global markets in nephrology, autoimmune, and anti-tumor therapeutic fields.
OVERSEAS GMP COMPLIANCE AUDIT
Rich international GMP on-site audit experience
Good communication skills with foreign official audit teams
Rich experience in the formulation, implementation and coordination of on-site audits and follow-up rectification plans
On-site GMP audit pass rate 100%
Accumulatively passed 30+ on-site audits, such as Korea KFDA/Brazil ANVISA/Egypt MOH/Peru DIGMIED/Indonesia BPOM/Pakistan DRAP/Russia ABBOTT, etc.