Services: Nonclinical Safety
Our nonclinical safety team, composed of regulatory toxicologists, pharmacologists and scientists, has experience in the design, optimization and review of nonclinical development programs over a broad range of therapeutic classes, involving small molecular entities, biotechnology-derived products, vaccines, and medical devices.
Our experts provide streamlined, nonclinical testing strategies to meet regulatory agency requirements in the most cost-effective and time-efficient manner, manage nonclinical programs, author and review regulatory submissions, and act as toxicology experts at corporate and regulatory meetings.
Over the past five years, our nonclinical experts have been involved in more than 290 toxicology studies including absorption, distribution, metabolism, and excretion (ADME); safety pharmacology; single and repeated dose toxicology; carcinogenicity; genotoxicity; developmental and reproductive toxicology; immunotoxicology; special toxicology; and biocompatibility studies.