-
Product information research: such as selection of reference preparations, research on prescription and process of reference preparations, research on pharmacological properties of raw materials, patent analysis, and feasibility research on product development;
Reference formulation research: such as reverse analysis of reference formulation process, determination of physical and chemical properties of reference formulation, and stability research of reference formulation;
Research on raw materials: study of pharmacological and chemical properties of raw materials (such as particle size method development, solubility determination under different pH values/solvents), stability research of raw materials.
-
Formulation prescription process development
Prescription process research: including small-scale prescription process research, pilot-scale amplification, process validation, application material writing, and supplementary research on supplementary materials;
Quality research: including the development of analytical methods (such as content, related substances, dissolution methods, etc.), validation of analytical methods, stability studies, etc.
-
Consistency evaluation of generic drugs
Reference formulation research: reverse analysis of formulation process of reference formulation, determination of physicochemical properties of reference formulation, quality comparison between reference formulation and generic formulation;
Raw material/excipient/packaging research: supplier screening, physical property research (such as particle size, crystal form, flowability, etc.), compatibility research of raw materials and excipients, packaging material selection, packaging material compatibility testing;
Formulation prescription and process research: conduct prescription and process research based on the customer's existing production line, complete pilot scale, process validation, and product application;
Quality research: development and validation of analytical methods for raw materials and formulations, stability studies for reference and generic formulations.
-
Clinical trial drug production
Equipped with a cGMP workshop for solid oral preparations, it can be used for the production of Phase I and II clinical trial samples.