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Services include contract research and development and analysis for the purpose of regulatory dossier development as well as the corresponding registration applications


Production process study
Route investigation and determination: Laboratory & pilot level
Key starting materials and intermediates control
Process transfer


Characterization

API Structure identification
Impurity synthesis, isolation, structure identification (NMR / IR / LC-MS / MS / UV)


Quality research

Analysis method development, validation, transfer, re-validation

Specifications development and establishment
Working standard qualification
Stability studies
Influencing factors stability studies, accelerated stability

Studies and long-term stability studies


Registration Applications

Local drug registration application 

Draft DMF in CTD format with CMC dossier submissions
Provide consultation on the Chinese registration regulations and assistance of on-site inspections


   

   


 

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