Preclinical Development
Full-spectrum preclinical development consulting including toxicology, pharmacology, ADME, and IND-enabling studies.
Key Capabilities
- IND-enabling toxicology study design and oversight
- Safety pharmacology program development
- ADME/PK study strategy and interpretation
- Bioanalytical method development guidance
- Preclinical PK/PD modeling and simulation
- Species selection and dose extrapolation
- Regulatory toxicology strategy and IND preparation
Our Approach
Bionavigen's preclinical development consulting is grounded in 30+ years of hands-on experience designing and executing IND-enabling programs for biologics and small molecules. Our team has supported over 100 IND filings.
We provide expert guidance on study design, species selection, dose setting, and interpretation of preclinical safety data. Our deep understanding of FDA expectations ensures that preclinical programs are designed to support regulatory approval.
Our consultants work closely with CROs and internal teams to ensure that preclinical studies are conducted efficiently and generate the data needed to advance programs into clinical development.