We are a life sciences management consulting firm focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. We help our clients make the big decisions with respect to their investments in clinical and non-clinical development programs -- decisions that will save both time and money, lead to safer and more effective products, and help achieve optimal global market access.
...Delivered by Independent Experts with Exceptional Qualifications & Experience
Our highly experienced Partners and Expert Consultants are some of the most well-known and well-respected industry, academic and regulatory professionals in the world. They have played a major role in the development and regulatory approval of dozens of significant new products and have pioneered some of the most innovative modern approaches to biomedical product development and regulatory review. They include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management.
We offer services in product development and regulatory strategy, expert consulting, high-impact project teams, and management of client product development programs.
Contact us at info@NDApartners.com or call 540.738.2550 to discuss your requirements.