01. CMC Regulatory Consulting and Defect Analysis
Support for CMC registration and filing strategies
Technical issues and challenges in CMC development
Defect assessment based on filing goals
Support for regulatory agency meetings
02. Preparation and Review of Various Application Documents
Drafting and reviewing various meeting application documents
Drafting and reviewing application documents such as IND, NDA, BLA, ANDA, DMF
Drafting and reviewing CMC amendment documents
03. Writing and Reviewing of CMC Change Documents
Training in CMC regulatory for drugs in different fields (small molecules, botanical drugs, antibodies, cell and gene therapies, etc.)
Interpretation and training on CMC-related guidance
04. Due Diligence Related to CMC
cGMP compliance assessment
Quality control and assurance system evaluation
Production process inspection
Risk assessment