We help our clients make critical decisions with respect to their investments in the development of new medical products and address their greatest challenges, from selecting the right compound to enter the clinic, to designing highly efficient clinical development programs and successfully navigating the regulatory process. Our deep roster of world-class expert consultants provide strategic guidance and high-impact, actionable recommendations with an emphasis on practical solutions based on proven medical, scientific and regulatory principles and extensive experience with successful new product introductions.
We provide world-class expertise in all areas of medical products, including drugs, biologics, biosimilars, vaccines, generics, devices, combination products, and diagnostics.
Contact us at info@NDApartners.com or call us at 540.738.2550 to discuss how we can help you advance your development program, navigate regulatory requirements, evaluate new technologies, or supplement your in-house expertise. Representative examples of the types of engagements we conduct for our clients are outlined below.
Expert assistance in addressing complex medical or scientific issues, evaluating program design and results, interpreting clinical data, preparing regulatory submissions, rehearsals for and participation in regulatory meetings, assessing drug safety data, or filling a key slot on your advisory board.
Assembly of customized teams with the specific expertise needed to provide comprehensive analysis and actionable recommendations, conduct due diligence, evaluate product licensing opportunities, evaluate clinical programs, or manage regulatory submissions and interactions with the regulatory agencies.
When you need to supplement your management team with experts on a temporary basis, or access a virtual management team for development strategy and planning, program management, regulatory support, or business development and partnering, we can provide a flexible solution with just the right resources and expertise you need.
Technology and regulatory requirements change so fast that it's hard to keep up. When you need in-depth, up-to-date knowledge of specialty areas such as QTc and cardiac safety, abuse liability assessment, Animal Rule pathway, regulatory guidances, PKPD modeling, clinical trial simulations, REMS, or other highly specialized topics, we can deliver the strategic and tactical expertise you need.