01. Preclinical Development Strategy
Formulation/review of preclinical development plans
Assistance in designing in vitro / in vivo efficacy, pharmacokinetic, and toxicology testing protocols
Analysis of preclinical trial results and interpretation of experimental data
Assistance in patient selection
Analysis of preclinical deficiencies under specific regulatory targets (Pre-IND/IND/EOP2/NDA/BLA, etc.)
Feasibility assessment for special designations and pathways (ODD/RPDD/FTD/BTD/RMAT)
Regulatory agency meeting support
Support in designing clinical protocols
Preclinical CRO selection
GLP audits
Project evaluation
Due diligence
02. Document Submission
Preclinical modules in IND, NDA, BLA applications
Investigator's brochure
FDA Annual Reports/Developmental Safety Update Reports (Annual Report/DSUR)
Briefing documents for milestone meetings (INTERACT/Pre-IND/EOP1/EOP2/Pre-NDA/BLA, etc.)
Materials for special designations and pathways
03. Preclinical-related Training
Training in preclinical development and regulations for drugs in different fields (small molecules, herbal medicines, antibodies, cell and gene therapies, etc.)
Interpretation of preclinical guidance principles and analysis of FDA-approved drug cases