We offer a powerful solution for companies making the transition from discovery to product development organizations.

NDA Partners brings, in one coordinated engagement, the total intellectual capital required to design, implement, guide, and evaluate entire development programs. To do this, we combine two unique capabilities-project teams staffed with Premier Experts and a comprehensive process based upon our System for Optimal Product Development.

Premier Experts are a select group of medical product development practitioners with decades of experience, an international reputation in their area of expertise, and significant involvement in the review and planning of dozens of successful biopharmaceutical products and medical devices. They are individuals who are personally known to the founders of NDA Partners, highly respected for their expertise and accomplishments, and who have significant name recognition in the biopharmaceutical and medical device industries. Through its Premier Experts, NDA Partners is able to form truly expert project teams for each of the engagements that it conducts for its clients.

A second unique capability is our System for Optimal Product Development. The System is a comprehensive operational framework designed by the founders specifically for mid-stage biopharmaceutical companies. We drew on decades of experience in medical product development to create a methodology for the optimal design, implementation and monitoring of product development programs. The System consists of principles, guidelines, procedures and tools and incorporates scientific, regulatory, program management and market considerations in guiding key program investment decisions. It is adapted to the unique needs of each company to which it is applied and, unlike the more capital-intensive approaches used in large pharmaceutical companies, balances the need for optimization of opportunities for claims and conduct of in-depth studies against typical biotechnology company issues such as control of cash burn and pursuit of a liquidity event.

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