Toxicology & Drug Development Consulting
Providing nonclinical and safety support for clients developing gene therapies and New Animal Drugs
Partnering & Due Diligence
- Maximize the value of your early phase asset by understanding toxicology impacts on the global development program
- Identify safety risks, mitigation plans, and data gaps during due diligence
Gene Therapies
- Proof of Concept study design and endpoint selection
- Study management, Sponsor oversight, relationship management with contract laboratories
- GLP toxicology and biodistribution studies
Veterinary Drugs
- Design and execute CVM-concurred Target Animal Safety studies
- Complete Human User Safety risk assessments including design and execution of GLP toxicity studies
- Preparing regulatory submissions and meeting materials
