NDA Partners
World-Class Product Development And Regulatory Services

If you had to visit a doctor due to a health issue, would you be more comfortable going to a general practitioner who has a basic knowledge of all illnesses, or a specialist who has extensive experience and a deep understanding of your specific condition? When it comes to expertise— irrespective of the industry—no one would understand the importance of prior experience and attention to quality better than those experts with practical experience and a proven track record in that field. In the field of medical device development, NDA Partners meets the needs of its clients by providing specialized expertise through its core group of more than 100 top-tier Expert Consultants who are some of the most well-known and well-respected professionals in the industry.

"We utilize the very best talent available around the globe to deliver extraordinary value to our clients"

NDA Partners is a life sciences management consultancy and contract development organization (CDO). The company offers product development consulting and strategic advisory services to biopharmaceutical and medical device companies. It also offers litigation support and expert testimony services for law firms dealing with the complexities in patent infringement, supply chain failures, and product liability cases. The company assists investment funds with due diligence and helps address development, regulatory, and scientific issues faced by portfolio companies. It assists US companies in entering global markets and helps Asian and European biopharma and device companies navigate US regulatory requirements. NDA Partners’ full spectrum service portfolio includes development program planning and management, expert scientific and technical advice, operational planning and oversight, and QMS planning and implementation. In addition to medical devices, the company provides product development services to clients developing drugs and biologics, and thus has the expertise needed to work as a partner with its device clients in the development of combination products. “We have functional capabilities to work with our clients across their entire device development program life cycle even if it is a combination product—drug or biologic—setting us apart from other management consulting firms,” states Earle Martin, Co-founder and Chief Executive Officer at NDA Partners.

Addressing a Sea of Increasing Pressure on Device Developers

Increased regulatory compliance requirements and the growing complexity of technology in the medical device industry are prodding manufacturers to seek the best available expert assistance to help them design and execute their product development programs. At the same time, increased end-user expectations for exceptional performance, effectiveness, and safety from their devices compel medical device manufacturers to define and implement new testing strategies that result in products that surpass user expectations and the performance of products currently on the market. “We recognize the extraordinary challenges faced by our clients, especially early-stage companies with limited resources and product development experience. We assist them in making critical decisions based on their technology and planned uses and in addressing their most challenging product development issues,” asserts Martin.

This is a company of people who have been highly successful, are at a premiere stage in their careers, and want to pass on their experience to the next generation of medical product developers

A Unique Solution for Early- Stage Device Companies

In addition to providing high-quality product development and regulatory consulting services, the company has developed a unique and powerful capability for partnering with early-stage biopharma and medical device companies where it designs and manages their product development programs on a contract basis. As a CDO, NDA Partners provides a program manager and assembles a product development team that consists of top-tier experts with extensive product development experience. These teams are flexible in their makeup and can be adjusted as the required functional expertise changes over the course of the development program. This results in lower cost due to the assignment of team members on a part-time basis based on the current required level-of-effort, versus in-house staff that are paid on a full-time basis. For clients that have a small development team in place, NDA Partners will work with them in a collaborative manner whereby it supplements their team with Expert Consultants possessing functional expertise not available in-house. In addition to the assigned experts, the development team has immediate access to NDA Partners’ global base of Expert Consultants to assist in addressing any unexpected issues that arise.

The Right Expertise at the Right Time

NDA Partners plays a strategic role in turning its clients’ creative development ideas into marketed medical devices while ensuring compliance with the complex array of laws and regulations both in the US and globally. The company assists in the development of novel devices including medical equipment; mobile and analytical software devices; combination products; implants; in vitro, imaging, and companion diagnostics; and drug delivery devices. They help their clients determine optimal regulatory pathways and formulate effective development strategies while planning and managing crucial components of their development programs. They prepare and submit US and EU regulatory filings, manage regulatory affairs in the US and internationally, design and implement quality management and risk management systems, and address the full spectrum of technical and scientific issues that arise over the course of their clients’ development programs.

One of the biggest challenges faced by device companies is the level of operational systems that they need to put in place for quality. They sometimes fail to meet regulatory guidelines due to their lack of understanding of the requirements specified by the regulatory agencies for manufacturing and quality systems. This is an area where NDA Partners plays an important role. Quality management systems have always been a source of major concern within the medical community, and NDA Partners’ Expert Consultants assist their clients in understanding those requirements, implementing their QMS systems, training their staff, and conducting internal audits, while making sure that those systems will pass the scrutiny of an FDA audit.

Unmatched Comprehensive Functional Expertise

Unsurpassed talent cannot be subdued or overshadowed by any other trait and is of extraordinary value.

NDA Partners has established a leadership position in the medical device industry through the expert advice of a team consisting of some of the most well-known and well-regarded industry, regulatory, and academic professionals in the world. Its experts have played a vital role in the development and regulatory approval of significant new products, and many have pioneered some of the most innovative modern approaches to biomedical product development and regulatory review. “We all have grey hair,” chuckles Martin. “This is a company of people who have been highly successful, are at a premiere stage in their careers, and want to pass on their experience to the next generation of medical product developers. They advise them in the development of their products and even mentor them in modern approaches and best practices. This is part of our unique culture and a driving force of the company,” explains Martin.

The company’s ability to assign top-tier expert consultants on all engagements and its ability to provide the full spectrum of functional expertise for complete product development programs make it a “durable differentiator” in the industry. From bench to marketing authorization and its leadership in working with early-stage development companies, NDA Partners assists companies during the entire product development life cycle.

The list of experts is comprised of big names such as three former US Food and Drug Administration (FDA) Center Directors and 14 former Director or Deputy Director Division heads, the former Head of the UK Medicines and Healthcare products Regulatory Agency (MHRA), the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP), and dozens of highly accomplished former industry executives. With their unsurpassed knowledge of the product development and regulatory environment and familiarity with the review expectations in various agency divisions, NDA Partners’ Expert Consultants deliver extraordinary value to their clients.

All engagements are led by a Lead Consultant, who is an expert in the engagement subject area and the primary client contact, in conjunction with one of the Partners, who plays a role in determining engagement strategy and assists in final QA of work products. In addition, the engagement is staffed as needed with multidisciplinary Expert Consultants from its global network. On all engagements, the company ensures that the leadership and top-quality experts are in place to deliver the highest value in its recommendations and work products.

Future-Proof Roadmap

NDA Partners is a small company, but rapidly growing and already a well-known name in the industry. For the future, the company aims to continue to add to its outstanding base of Expert Consultants, further broaden its support capabilities, and expand its program management office to be able to support more full-program management (CDO) clients.

“We have the ability to put a program manager in place and run entire development programs for our clients, or we can complement our client’s staff by forming a larger team of qualified experts from both organizations and working together in a strategic partnership to develop their product. We utilize the very best talent available around the globe to deliver extraordinary value to our clients. This approach is driving our business and revenue, and that’s why our clients come to us and stay with us over the entire course of their development programs,” asserts Martin.