Clinical trial application & imported drug registration in China are highly demanding works. It is very critical to have well understanding of China Food and Drug Administration (SFDA) regulations. What’s more, the rich experience of having passed SFDA evaluation, handled drug sample test and drug specification verification in National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) will be the key to success in getting clinical trial and drug registration approval.

Our staffs have succeed in helping several multi-national companies (Novartis, AstraZeneca, Rambaxy, etc.) with clinical trial application and imported drug registration in China.

We provide professional services as follows:

• Dossier preparation for imported drug registration
• Application for clinical trial / marketing of imported drug
• Application for international multi-center clinical trials
• Consultation on on-site visit preparation