Our CMC department focuses on establishing large-scale synthetic routes along with formulation development and quality control, our drug categories can be proprietary drugs or generic drugs. All studies are complied with ICH and SFDA guidelines. Feasibility study Project planning Synthesis Establish synthesis “Freeze” the synthesis Establish large-scale Formulation Development Pre-formulation testing Formulation development Process optimization IVIV correlation Scale up Analytical Development Establish HPLC methods for API, impurities, isomers and drug product Develop HPLC method for stability testing Conduct HPLC method validation Set API and drug product specifications Stability Study Perform stability study for API and drug product under ICH & SFDA guidelines Regulatory Submissions Prepare documentation for regulatory submissions Prepare supporting documentation and data package Our CMC exper...
Integrated Drug Discovery Services- Chemistry, Biology & Preclinical Services