Lovelace Biomedical has an extensive record of successfully designing and executing regulatory toxicology studies for submission to U.S. and European regulatory bodies, including the FDA and EMEA, with capabilities to address regulations of other countries, as well. Our toxicology, bioanalytical, pathology and genetic toxicology capabilities are combined in a centralized facility, allowing us to efficiently conduct an array of IND-enabling studies.
Our scientists work closely with sponsors to design programs that achieve their goals while minimizing timeline and investment. Beginning with non-GLP investigational toxicology and dose-range finding studies, we focus on generating the data needed to support regulatory submissions. Our team is recognized for its excellence in tackling the many challenges of highly innovative drug classes and new delivery mechanisms, while also bringing the experience and foresight to proactively address the many unseen complexities of seemingly routine programs.