Non-Clinical Development
Non clinical and toxicology development services
First-in-human starts here. We make sure you are ready.
A weak non-clinical package delays IND clearance, triggers clinical holds, and gives regulators doubt where they need confidence. We bridge the gap between discovery and first-in-human trials by designing and overseeing the pharmacology, toxicology, and safety studies required for regulatory success.
We work across small molecules, biologics, cell and gene therapies, and combination products. Our scientists interpret data through a regulatory lens from day one, ensuring your non-clinical package tells a coherent, submission-ready story.
What we deliver
- IND-enabling study design and GLP oversight
- Non-clinical strategy for pharmacology, toxicology, and safety pharmacology of a drug or biologic
- Authoring of non-clinical overviews and summaries
- CRO selection, oversight, and quality assurance
- Regulatory response support for FDA/EMA information requests
- Species selection, dose justification, and first-in-human dose bridging
Where we outperform
- Deep experience across novel modalities like ADCs, CGT, mRNA
- Integrated with regulatory strategy from study design onwards
- Tight CRO governance to keep GLP studies on time and audit-ready
- Proactive alignment with relevant regulatory agencies to prevent clinical holds before they happen
