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NDA Partners – A Life Sciences Management Consulting Firm Focused On Providing Product Development And Regulatory Services

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Below is our recent interview with Earle Martin, Co-founder and Chief Executive Officer of NDA Partners:

Q: Could you provide our readers with a brief introduction to NDA Partners?

A: NDA Partners is a life sciences management consulting and contract development organization (CDO) that provides product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries. The company was founded in 2003 by ten former pharmaceutical industry and FDA executives who pioneered some of the most innovative modern approaches to product development and regulatory review and played major roles in the development and regulatory approval of dozens of new medical products. Since then, the company has expanded to 14 Partners and 115 Expert Consultants providing services to more than 150 clients worldwide.

NDA Partners’ core client base consists of early-stage innovator companies and small-to-medium size biopharma companies with a limited portfolio of new products in development. Most of these companies are investor-funded and face the constant challenge of meeting milestones attached to the last round of funding and closing the next round. NDA Partners is experienced in working in this challenging and dynamic environment and plays a key role not only in assisting clients in meeting funding milestones, but also in enhancing their credibility with investors through the assignment of highly experienced Expert Consultant teams to advance their development programs in the most efficient manner, and with the highest likelihood of regulatory success. NDA Partners’ clients are tomorrow’s industry leaders, and we help them build a successful business and make a difference.

Q: Can you give us insight into your services?

A: NDA Partners provides guidance and support throughout the product development life cycle, from initial concept to marketing authorization. Services include product development and regulatory strategy, expert scientific and technical advice, operational planning and oversight, and development program planning and management. The company helps early-stage biopharma 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. The company 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.

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Q: What makes you stand out from your competition?

A: The company distinguishes itself from other consultancies through its ability to assign recognized 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 bench to marketing authorization, and its leadership in working with early-stage development companies. The NDA Partners consultant base currently consists of 14 Partners and 115 Expert Consultants. This includes 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. Areas of expertise in the consultant base include product development and regulatory strategy, nonclinical development, clinical pharmacology, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, and regulatory submissions. NDA Partners’ expertise and scope of services is unmatched in the industry.

Q: What would you say was the single most influential factor in your business success?

A: The company’s Partners and Expert Consultants possess an unsurpassed knowledge of the product development and regulatory environment and are thoroughly familiar with the review expectations in various regulatory agency divisions. By utilizing the very best talent available anywhere in the world and providing expertise in all functional areas of medical product development, NDA Partners delivers extraordinary value to its clients.

Q: What does the future hold? Where is the company headed?

A: The industry model for development of innovative new products has shifted from big pharma to small biopharma companies over the past ten years. These small firms generally lack the experience and comprehensive functional skills needed to effectively conduct development programs in-house. To address this opportunity, NDA Partners has developed a unique and powerful capability for partnering with inventors, discoverers, and owners of intellectual property and early-stage biopharma 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 relationship 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. CDO services represent a major growth opportunity for the company and an industry-changing option for development of new medical products.

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