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about mdi Consultants

mdi Consultants, Medical Device, Pharmaceutical, and Food Industries Consultants

mdi Consultants Inc., an FDA Consultant, and trusted partner in the sphere of FDA regulatory compliance, specializes in a comprehensive array of services tailored to the Medical Device, Pharmaceutical, and food Industries, with a focus on FDA Regulatory Compliance. mdiConsultants excels in guiding businesses through the intricate landscape of FDA Medical Device Compliance, FDA Pharmaceutical Compliance, and FDA Food Industry compliance, to ensure adherence to the regulatory compliance standards set by the U.S. Federal Food and Drug Administration.

For the Medical Device, Pharmaceutical and Food industries, MDI Consultants stands as a beacon of expertise, offering tailored solutions to meet and achieve compliance requirements. The company’s adept team of EU and FDA consultants, provide invaluable insights and support, helping you to navigate the complex regulatory frameworks to achieve and maintain compliance with EU and FDA regulatory authorities.

mdi Consultants is a go-to resource as your company’s FDA U.S. Agent, with a deep understanding of the U.S. regulatory landscape, and serves as your strategic partner, facilitating communication between international businesses and the FDA, and ensuring your organization meets and exceeds the quality standards necessary for FDA approval and maintenance of your products.

From FDA Compliance to quality management systems to documentation, and with its client-centric approach, mdi Consultants commitment to excellence, coupled with its extensive industry knowledge, positions it as a premier choice for those seeking a partner in FDA regulatory compliance regulated industries.

About mdi Consultants’ Approach

We utilize the following three part approach to providing high quality services to our clients.

Unsurpassed FDA consultant experience

We identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes

We have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development

We stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor)

About mdi Consultants’ Staff

The company’s principals, Alan P. Schwartz and Dr. Anand Akerkar have carefully selected a group of consultants who have accumulated extensive industry experience dealing with U.S., European and Canadian compliance concerns. Our staff has deep knowledge in all FDA compliance issues (e.g. device and pharmaceutical submissions, quality system compliance, clinical trial management, Food Safety, HACCP) as well as European compliance issues (e.g. ISO 9000, ISO 13485, ISO 22000, CE Mark, MDD, IVDD, AIMDD). The staff includes a number of former FDA officials, ISO lead assessors and industry quality managers.

Anand Akerkar, Ph.D.

Anand Akerkar, Ph.D.

President and Chief Executive Officer

Dr. Akerkar has over 50 years of experience in the healthcare industry. Anand held several senior management positions at Ciba Giegy, Becton Dickinson, and Technicon Corporation. Dr. Akerkar has successfully managed the development, launch and management of in-vitro diagonostic products. While at Becton Dickinson, he was a member of the industry review board for the FDA that helped to define the 510(K) submission requirements and other clinical chemistry standards. Dr. Akerkar holds 11 patents and has been published over 150 times in recognized scientific journals. Dr. Akerkar has been a consultant to the healthcare industry since 1986. Dr. Akerkar was the Scientific Advisor to ex-U.S. Congressman Benjamin Gilman. He has been President and CEO of mdi since 1994.

Alan Schwartz

Alan Schwartz

Executive Vice President

Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the FDA in 1978 to start his consulting career. Alan has implemented over 100s of quality systems and led numerous companies worldwide successfully through FDA audits and ISO certification. Alan has trained over 15,000 individuals in the FDA regulations and the QSR/cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and was a member of the industry group that defined HACCP regulations. He has been Executive Vice President of mdi since 1994.

mdi Global locations

mdi Consultants’ Locations

We are headquartered in Great Neck, New York (just outside of New York City) and have 11 representative locations worldwide. Our US and other international locations include:


Charlotte, NC
Knoxville, Tn
Los Angeles, CA


Rillieux-la-Pape, France
Hamburg, Germany
Seoul, Korea
Shenzhen, China
Sialkot, Pakistan
Mumbai, India