R&D center

Registration, approval and transfer in Chinese market

We have an experienced work team for the registration of drug in China and international market, and they are familiar with relative registration laws, regulations and declaration procedures. Most of responsible personnel has been working in this field for more than six years, and have helped several materials and preparations passing the declarations. Our lab is well equipped with leading analysis and inspection apparatus, including LC (Schimadu and Agilent), GC, moisture teller, polarimeter, ultraviolet spectrometer; reparation room is well equipped with several lab test machines such as coating pan, sterilization pan, emulsion machine and freezing dryer, etc; thus it can meet the requirements of formulation selections.  Up to now, we have helped several enterprises getting registration licenses, including HPMC eye drops, adefovir dipivoxil materials and tablets, HES materials and injection, asarone materials and injection, Foscarnet Sodium materials and injection, Amlodipine Besylate dispersible tablets, Tiopronin materials and enteric coated tablets, Felbinac materials and gel, Liranaftate materials and ointment, pazufloxacin mesilate materials and injection, Lafutidine materials and tablets, and so on.

Now, we can offer registration declaration of chemical APIs and preparation in China, and all procedure service from lab test, pilot-scale experiment, industrialization, quality research (all or part), stability research and formulation selection to the check of methods and equipment, etc. At same time, we also offer registration declaration of imported drugs and one package service, including document translation, assemble, the complementarity and amendment of relative documents which may be required by Chinese laws and regulations, making declaration and approval of license. Following the laws and regulations closely, we are working hard to offer you up-to-date declaration registration documents.