About

Calvert Labs is a highly respected contract research organization specializing in the discovery and development of potential pharmaceuticals. In addition to lead identification and lead optimization services, we provide a wide array of preclinical services to help our clients navigate their GLP testing needs prior to advancing their discoveries into clinical trials.

We are experienced in many classes of compounds and offer capabilities in the performance of studies to support the safety evaluation of drugs, biologics, proteins, peptides, gene therapy compounds, monoclonal antibodies, and other chemicals, as well as devices from not only the discovery phase, but through the preclinical phase to IND submissions. Calvert also performs studies to support NDA submissions.

Preclinical Capabilities

• Toxicology
• Pharmacology
• Immunology – Immunotoxicology
• Pharmacokinetics – ADME
• Telemetry
• Bioanalytical Services

Our senior scientists have a collective 100+ years experience in the design and submission of preclinical development programs to various regulatory agencies located all over the world (FDA, Health Canada, MHLW, OECD (Europe), AAALAC, EPA, USDA, OSHA).

Never in the 40-year history has a study been rejected by any international government health service regulatory body for design or conduct.

Our labs were inspected by the FDA in August 2004, October 2006, and May 2009—no 483s were issued.