Regulatory guidance and Interpretation of global regulations in accordance with ICH, China NMPA, US FDA, and EMA guidelines, and other global regulations
Preparation of Pre-IND package and Meeting packages, Interaction with HA and Response to IRs from HA
Setting of phase-appropriate testing acceptance criteria for specifications
Analytical comparability exercise from IND phase to Post-BLA
CMC Risk assessments for raw materials, manufacturing process, testing, formulation, container closure and format changes
