About

President

Dr. Shroff retired from the Food and Drug Administration (FDA) as Deputy Director, Office of Enforcement on June 30, 2000. He has 26 years of service with the agency in various capacities (review chemist, compliance officer, Branch Director, Division Director and Deputy Office Director).

During the last fifteen years, Dr. Shroff helped direct and coordinate the enforcement activities of the agency in all five program areas ( Drugs, Medical Devices, Biologics, Foods and Veterinary Medicine), including developing enforcement policies, compliance and regulatory activities; coordinating specific legal actions; and managing program issues.

Dr. Shroff worked closely with the Office of the Commissioner, the Office of Chief Counsel, FDA Centers (CDER, CBER, CDRH, CVM, CFSAN) and FDA District and Regional Offices. In addition Dr. Shroff supervised programs that required interaction with other federal agencies, state and foreign governments.

Dr. Shroff has served in various capacities at the FDA since joining the agency in 1974. Prior to joining the FDA, Dr. Shroff worked for Ortho Pharmaceutical Corporation –a subsidiary of Johnson & Johnson for eleven years. Here he was involved in various phases of product development – from synthesis to pre-clinical research/development to post-marketing activities.

In addition to a number of technical and management training courses, Dr. Shroff has graduate training in government management, he participated in the program for senior managers in government at the John F. Kennedy School of Government.

Dr. Shroff has authored more than 60 scientific and technical publications and holds thirty United States and foreign patents. He also has received numerous awards from FDA ranging from the Commissioner’s Special Citation to the Award of Merit to the Commendable Service Award to Group Awards for special accomplishments.

Presently, Dr. Shroff serves on the Editorial Advisory Board of the FDA Enforcement Manual – a Thompson Publishing Group publication. In the past he has served on the Board of Directors for the Regulatory Affairs Professional Society (RAPS) and Editorial Advisory Board of Pharmaceutical Technology Journal.

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Associates

ARVIN SHROFF ASSOCIATES, LLC has a pool of former FDA and industry associates. They include:

Review chemists

Compliance officers

Investigators

Engineers

People who have prepared FDA submissions for industries

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Contact

Arvin P. Shroff, Ph.D.
President
10560 Edwardian Lane
New Market, Maryland 21774-6229
Telephone: 301-865-7402
Fax: 301-865-7403
Email: shroff@arvinshroff.com