Our company was founded in 2003 by a distinguished group of ten industry practitioners, former senior regulatory agency staff, academic experts and business people who have, collectively, played a major role in the development and regulatory approval of more than two dozen new products and pioneered some of the most innovative modern approaches to medical product development, including:

• Single clinical trial approval standard (FDAMA Sec. 115a)
• Use of surrogate endpoints for accelerated regulatory approval
• Quantitative approaches to dosage optimization
• Rolling NDAs
• Modeling and simulation of clinical trials
• Learning and confirming paradigm

Our business model was specifically designed to attract and retain the world's top product development experts, harness their collective knowledge and experience, and apply their skills in a practical manner to achieve significant improvements in how product development is conducted in the biotechnology industry. The result is a firm focused on improving the success rate and speed of medical product development with a well-thought-through approach that meets the needs of investors as well as company management.

• What We Do
• Unique Capabilities
• Where We Started
• Expertise
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