At Biomodels, we save our clients time at multiple levels of the drug development process resulting in a significant cost savings and a distinct competitive advantage. For example, we have documented success shortening the pre-clinical phase in support of an IND application for our clients. On average, it takes approximately four years between identification of a potential drug candidate and the filing of an IND application for the initiation of human testing (1,2). We routinely cut this time by at least half, and more in select cases. We enable this two-year timesaving by emphasizing a highly personalized level of service at all stages of the engagement beginning with an initial consultation and proposal. Once the proposal is finalized, clients benefit from the experience of the Biomodels team in completing high quality studies designed with FDA expectations in mind.

1. Fundamentals of U.S. Regulatory Affairs (2007), 5th edition, Regulatory Affairs Professional Society: Rockville, MD.

2. The Comparative Status of the U.S. Pharmaceutical Industry: The Influences of Technology In Determining International Industrial Competitive Advantage (1983), The National Academies Press: Washington, D.C.