Who said you can’t have it all?
We’ve joined ProPharma and expanded our great team of Expert Consultants and service offerings. Learn more about our elevated capabilities.

Services

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.

Expert Advisory Services

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).

Contract Development Teams

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.

Specialized Service Offerings

NDA Partners' statisticians offer traditional and advanced expertise to companies developing medical products, including new drugs, generics, biologics, devices, and combinations. NDA Partners offers a depth of expertise in traditional frequentist statistics as well as adaptive trial design, Bayesian statistics, and Model-Informed Drug Development.

NDA Partners Experts Include:

William Fairweather, PhD, PSTAT Jennifer Geis, PhD Tara Maddala, PhD


NDA Partners’ Expert Consultants offer traditional and advanced market access and reimbursement expertise and operational assistance to companies developing medical products including market access landscape assessments, coding strategy development, and payer dossier preparation prior to launch for new drugs, generic drugs, biologics, traditional medical devices, in vitro diagnostics and laboratory-developed tests, and combination products.

NDA Partners Experts Include:

Shauna Burns Catherine Gendrolis Girish Putcha, MD/PhD Michele Schoonmaker, PhD


NDA Partners offers a comprehensive range of services services to assist its clients in the development and registration of new products for pediatric patients, and for obtaining pediatric market exclusivity. These services include the design of pediatric studies, preparing and filing Pediatric Study Plans or Pediatric Investigation Plans, employing Model-Informed Drug Development, obtaining Rare Pediatric Disease Vouchers, and more.

NDA Partners Experts Include:

Francesca Joseph, MD Kana Mizuno, PhD Tomoyuki Mizuno, PhD Joseph Rosenthal, MD Brian Tseng, MD, PhD Alexander A. Vinks, PharmD, PhD, FCP


NDA Partners’ quality experts help clients turn creative ideas into marketed medical devices while ensuring compliance with a complex array of laws and regulations, such as ISO 13485 and 21CFR820, in the US and internationally. NDA Partners experts have the knowledge and industry and regulatory experience to design, implement, and manage quality and risk management systems, conduct current Good Manufacturing Practices (cGMPs) and current Good Clinical Practices (cGCPs) audits to ensure regulatory compliance, and address critical issues that arise during development programs.

NDA Partners Experts Include:

Richard Aleman Julie Ballard Roberta (Bobbi) Druyor-Sanchez, MS Lauren Bronich-Hall, MS Donna Hartzfeld, PhD Becki Hiebert, MBA Leanne Kiviharju Cynthia Koeneman, MBA Cortez McBerry, PhD Andrea Miller Angela Occhionero Robert Rej, PhD Sam Rua Jeffrey Taub Shelley Wistar





NDA Partners can help clients understand and respond to the complexities of working both with the FDA and United States Pharmacopeial Convention (USP) to properly apply USP standards, advance public monographs, and meet quality requirements.

NDA Partners Experts Include:

Richard Aleman David Savello, PhD Vinod P. Shah, PhD Eric B. Sheinin, PhD Srini Srinivasan, PhD Roger Williams, MD


Expert Witness Services

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.

NDA Partners Joined ProPharma

Together we are elevating our services as the leading global provider of regulatory sciences, clinical research solutions, life science consulting, pharmacovigilance, and medical information services.

See Our Expanded Services

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