Preclinical Safety & Toxicology
Our PhD-level toxicology consultants help our clients develop toxicology testing plans consistent with the stage of preclinical development and FDA requirements. From in vitro to in vivo studies, our preclinical toxicology team can provide the expertise to cover all aspects of the preclinical phase of development for drugs, medical devices and other health care products. We can help identify the key preclinical toxicology issues, and devise a testing plan to address them in the most cost-effective (“cheapest and fastest”) approach. We work with many testing laboratories and know their strengths and weaknesses and which ones would better fit your needs.
Our preclinical safety and toxicology services include:
- Literature review and technology assessment
- Review of existing preclinical safety testing plan and relevant data
- Full study design of safety pharmacology, genotoxicity, ADME/ pharmacokinetic and repeat-dose toxicology studies
- Contract laboratory identification, proposal review, pricing negotiations, and study monitoring
- Toxicology risk assessment for human exposure and clinical trials
- GLP study report writing (See our Medical Writing Services)
Their guest seminars on the importance of an early “regulatory and technical gap analysis” have helped many start-ups identify critical steps that must be addressed for them to get their plan in place, and to obtain key funding milestones. – Carol Frankenstein, President of BIOSTART, Cincinnati, OH