Our services include but are not limited to:

Reasonability analysis of definition and control of starting materials;

Assistance in establishing specifications for critical intermediates and finished products;

Standardization of process description;

Standardization of method validation and impurity research;

Assistance in drug registration inspection and specification review;  

The rationality of solvent recovery;

Registration inspection and sample customs clearance import;

R&D and registration of extraction APIs, fermentation APIs and semi-synthetic APIs

Compliance guidance for strain identification and cell bank construction

Good tracking, resolving the drug regulatory agency's questions at any time