NDA Partners® provides a comprehensive range of services across the product development life cycle for drugs, biologics, biosimilars, vaccines, generics, devices, combination products, and diagnostics. In addition to multi-disciplinary teams that provide custom solutions, NDA Partners’ clients have immediate access to the company’s entire base of Expert Consultants worldwide to call on for ad hoc advice or to answer critical questions that emerge during their development program.

NDA Partners provides high-value advisory services through its worldwide base of top-tier Expert Consultants to support the product development life cycle, from initial concept to marketing authorization. Advisory services include product development and regulatory strategy, development program planning and management, and expert scientific and technical advice. NDA Partners’ experts are highly experienced with the preparation and submission of applications including INDs, ANDAs, NDAs, BLAs, PMAs, 510(k)s, and special designations, and can act as the primary FDA contact on behalf of a client. In addition, NDA Partners can take on leadership roles such as membership on Scientific Advisory Boards or working on a part-time basis as an interim executive (e.g., Chief Medical Officer, Head of CMC, and Head of Regulatory Affairs).

NDA Partners has developed a unique and powerful capability for partnering with inventors, discoverers, and owners of intellectual property and early-stage biopharma and medical device companies as a contract development organization (CDO). For these clients, NDA Partners forms world-class product development teams (PDTs) that design, plan, and manage their product development programs. Benefits of an NDA Partners PDT include project teams consisting of highly respected top-tier Expert Consultants with proven track records in product development, enhanced credibility with prospective investors, avoidance of equity dilution associated with awarding stock options to in-house staff, rapid program initiation, immediate adaptation of team composition as the required functional expertise changes over the course of the development program, and immediate access to supporting Expert Consultants in specialized areas as needed.

NDA Partners provides litigation support services for the major law firms serving the pharmaceutical industry in cases involving claims such as antitrust violations, patent infringement, product liability, and supply chain failures. Services are provided by top-tier experts, including former FDA and industry senior executives, and may encompass expert reports, depositions, and trial testimony.

Contact us at info@NDApartners.com or call 540-738-2550 to discuss your requirements and learn more about how NDA Partners can help you design and execute a world-class product development program.