PRECLINICAL DEVELOPMENT
- Non-GLP toxicology, PK-PD
- CRO assessment, protocol development, study monitoring
- GLP Toxicology, PK-PD
- Mechanistic toxicology
- Data and report reviews
- Translational Biomarkers
- Pre-IND and IND
- Full IND, BLA, and NDA enabling nonclinical toxicology, DM-PK
- BLA or NDA filing