Exponent’s Health Sciences professionals bring the skills and experience necessary to assist you in the design and completion of complex preclinical drug development programs. Our toxicology staff has expertise in numerous sub-disciplines of toxicology and clinical toxicology and provides consulting in nearly all phases of drug development from preclinical studies to post marketing safety assessment. We can assist in the coordination and management of traditional nonclinical toxicology and safety pharmacology studies designed to meet regulatory requirements as well as design and manage studies to address unique issues observed with your product.
Exponent scientists have extensive experience in product safety research and evaluation and can assist pharmaceutical and biotechnology companies to meet the growing demands required for both US and worldwide product approvals. The most common services provided are listed below. Please contact one of our senior drug development consultants to discuss your specific needs.
Preclinical Development Services
- 505(b)1, 505(b)2, 505(j) submissions
- Small molecules and biologics
- Data review and lead candidate selection
- Target product profile development
- Preclinical development strategy to support regulatory submissions
- Preclinical study design and protocol development
- CRO selection and study management
- Pharmacology and efficacy studies
- Pharmacokinetics and ADME
- Genetic toxicology
- Safety pharmacology
- Developmental and reproductive toxicology
- Embryo-fetal development mechanisms
- Juvenile animal studies
- Single and repeat dose toxicology
- Carcinogenicity and dose setting for CAC SPA submission
- Mechanistic toxicology
- PBPK modeling
- Biostatistics
- Preparation for and representation at FDA/regulatory authority meetings
- Interactions with FDA and other regulatory authorities
- Paper and/or eCTD preparation of regulatory submissions ((IND/NDA, CTA/MAA, BLA, ANDA etc)
- Study report management and writing
- Preclinical issues research and resolution