2019 Biotechnology Awards

10 GHP / 2019 Biotechnology Awards , NDA Partners LLC NDA Partners LLC: Best Life Sciences Management & Contract Development Organisation 2019 - USA NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, andmedical device industries worldwide. Having recognised the firm in this year’s Biotechnology Awards, we profile it to find out more and explore the secrets behind its phenomenal success. Founded in 2003, NDA Partners assists its clients in making critical decisions with respect to their investments in the development of new medical products and addressing their greatest product development and regulatory challenges. These range from selecting the right compounds to enter the clinic to designing and executing highly efficient product development programs that lead to marketing authorizations in the US and EU. The firm’s core client base consists of more than 200 companies worldwide, many of which are early-stage innovator companies with limited resources and small portfolios of the new products in development. NDA Partners distinguishes itself from other consultancies through its ability to assign top-tier Expert Consultants on all engagements, its ability to provide the full spectrum of functional expertise needed to conduct complete product development programs from the bench to marketing authorization, and its leadership in working with early-stage biopharma and medical device development companies. The highly experienced Principals and Expert Consultants of NDA Partners include three former FDA Center Directors, the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, 36 Expert Consultants with prior experience within the FDA including 23 at the Division Director/Deputy Director level, five with senior level experience in EU regulatory agencies, dozens of former industry product development executives, and academic practitioners and opinion leaders. The experienced and dedicated staff and Expert Consultants within NDA Partners work together to provide a wide range of services, which include product development and regulatory strategy, expert scientific and technical advice, operational planning and oversight, and development program planning and management. NDA Partners helps early-stage biopharma and medical device companies identify the most appropriate regulatory pathways, prepare effective preclinical and clinical development plans, design efficient and informative study protocols, assess data, evaluate readiness for regulatory submissions, prepare for meetings with regulatory agencies, and submit regulatory applications. It helps Asian and European pharmaceutical companies navigate US regulatory requirements and assists US companies entering global markets. In addition, the firm assists investment funds with due diligence and in addressing difficult development, regulatory, and scientific issues faced by portfolio companies, and is a major provider of litigation support and expert testimony services for law firms dealing with the complex issues of patent infringement, product liability, and supply chain failures. 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 development teams that design, plan, and manage their product development programs. Benefits of an NDA Partners strategic relationship include project teams consisting of highly respected top-tier Expert Consultants with proven track records in product development, enhanced credibility with their 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. Ultimately, its world-class expertise and product development management practices combine to ensure that NDA Partners offers its valued clients a truly unique range of services that they cannot find elsewhere. Looking ahead, the firm will continue to enhance its base of Expert Consultants and service offerings to ensure that it remains ahead of the emerging industry developments and continues to offer cutting-edge support to every client it has the privilege to work alongside. Contact Details: Company: NDA Partners LLC Contact: Earle Martin Address: 40 Commerce Lane, Suite D Rochelle, VA, 22738, USA Phone: +1 540 738 2550 Website: ndapartners.com

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