In past 7 years, Hanvet’s experienced Regulatory Affairs team has been obtaining more than 6 New Drugs Certificates in China, which made Hisun to be the holder holding the most New Drug Certificate in China for companion animal healthcare products.
All the New Drug Certificate required Hanvet’s effort for the R&D, process study and manufacturing study. More than that, all New Drug in China required complete trials of Pharmacokinetics, Efficacy study, Safety study, performed by authorized university or institute, in order to ensure the safety, effect and quality assurance. To make customers use regulated and reassured products is Hanvet’s persistent pursuit.
Apart from domestic registration, Hanvet is also working for international projects’ registration work. If customer has intention to register their own products in China, Hanvet is willing to cooperate together with customer for the marketing and registration analysis. To further step, Hanvet’s professional Regulatory Affairs team will organize the registration according to Chinese Import Drugs application guideline.
Besides of basic documentation preparation, Hanvet is capable to organize registration relative studies:
o Pharmacokinetics study
o Efficacy study
o Residue study
o Target animal safety study