NDA Partners, a ProPharma Company
Business Consulting and ServicesDistrict of Columbia, United States51-200 Employees
NDA Partners, part of the ProPharma family, provides consulting services to life sciences organizations, concentrating on product development and regulatory strategies for drugs, biologics, and medical devices around the world. Its leadership comprises former regulators and industry leaders, including ex-FDA Center Directors and senior executives from USP, together with an international network of more than 100 former pharmaceutical and regulatory professionals. The firm draws on expertise spanning nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and program management. Offerings range from overarching development and regulatory strategy to program design and management, as well as expert consultation, team-based solutions, project-focused engagements, and clinical trial design and management. Headquartered in the Washington, DC area, the company positions itself as a partner with deep regulatory and development know-how to help clients navigate complex pathways to market. In 2023 the firm added new expert consultants, including Michele Schoonmaker, signaling ongoing expansion of its specialist capabilities.