Designing and implementing a rapid and valuable safety and efficacy program is key to defining the potential of new compounds in your pipeline. By partnering with Charles River, you can rely on our scientific, program management, and regulatory expertise to help you make the right choices.
Pharmaceutical and biotechnology companies must show evidence of their compound’s biological activity and provide data indicating that the drug is reasonably safe and effective before initial administration into humans. Safety assessment or nonclinical testing is the first major step toward regulatory approval. In addition to this crucial pharmacology and toxicology information, a compound’s chemical composition and the manufacturing procedures on how to best formulate the drug for its intended clinical use must be identified.
With facilities on three continents, Charles River offers a full range of in vitro and in vivo safety and efficacy testing in compliance with global regulatory agency guidelines. In addition, our research models and related services, process manufacturing support, and laboratory services, including formulation development, can meet all your preclinical needs and more. Our scientific consultants and regulatory advisors can help interpret the preclinical data and assist in the design of initial-stage clinical protocols.