Drug development platform
Pharmaceutical research
Formulation and process development; Preparation prescription disassembly and reverse engineering; Formulation adjustment and process optimization; Transfer of prescription technology and analysis methods; Process validation at or above the pilot scale; Establishment of formulation quality standards and validation of analytical methods.
Consistency evaluation service
Guidance and filing for the selection of reference formulations; Comparative study on in vitro dissolution and dissolution curves of products and reference formulations; Redevelopment of generic drug prescriptions and processes; Supplementary research required for consistency evaluation.
Supplementary drug research
Develop a plan for CDE's supplementary response, supplement experiments, and write response materials.
Third party detection and impurity research
Research on prescription reverse engineering, related substances, optical isomers, content, residual solvents, genotoxicity impurities, element impurities, packaging compatibility, etc.
Clinical Services
As a one-stop research service platform, we provide you with comprehensive technical services and solutions from preclinical to clinical stages, improving clinical research efficiency, saving time and costs.