Nonclinical testing is often the first step in demonstrating the potential safety and effectiveness of a healthcare product. The design of the nonclinical testing program can greatly influence a sponsor’s ability to initiate clinical studies. Our nonclinical services include integrated drug development planning, gap analysis, timeline optimization, expert assessment of specific issues and/or safety concerns, and bridging strategies (including 505[b] and biosimilars). We have extensive experience in efficiently devising and executing integrated nonclinical development strategies for drugs, biologics, devices, and combination products for multiple therapeutic indications and routes of administration.
The nonclinical testing program must be designed to meet or exceed current regulatory expectations but is also the optimal balance between risks and corporate goals. We have been involved in thousands of different nonclinical studies allowing them to provide realistic, first-hand, boots on the ground, detailed support for study execution, including request for quotation (RFQ) and program costs negotiation, laboratory selection, study protocol design and review, study monitoring, data and report review, and integrated nonclinical analytical and bioanalytical support.
Through our extensive exposure to a wide variety of products and review divisions, our nonclinical experts can provide streamlined and educated support for small molecules, biologics, vaccines, monoclonal antibodies, antibody-drug-conjugates (ADCs), gene therapy products, combination products, and various medical devices for a wide range of therapeutic. We can assist with providing nonclinical support for healthcare agency interactions; authoring and review of nonclinical submission packages; preparing special protocol assessments (carcinogenicity studies); and addressing special concerns and nonclinical safety assessments.