Medical Devices
Entrepreneurial Experience


Medical Devices

Dr. Norman F. Estrin is a recognized authority in the medical device and cosmetic industries. He has had over 25 years of experience in directing scientific and technical programs in these industries.

As President of Estrin Consulting Group LLC, Norm has built upon and added to his experience and contacts while Vice President, Science & Technology at the Health Industry Manufacturers Association (HIMA).

Dr. Estrin has addressed representatives at the Ministries of Health in Singapore and Beijing on regulatory issues and, on the invitation of the National Research Council of the National Academy of Sciences, gave a week-long course on regulatory issues to the Division of Medical Sciences and Thai FDA. Norm presented a keynote address at a conference organized by the Centers for Disease Control on prevention of device-mediated bloodborne infections. He also presented a series of workshops on how to do effective medical device submissions. Dr. Estrin testified before a Congressional Committee on nitrosamine contamination of cosmetics and appeared on the TV news show "20/20" on animal testing issues.


Dr. Estrin has gained much experience in guiding startup companies. He has prepared business plans, budgets, projections and established links to essential sources of financing for companies, such as Medictor Technologies, Theri-Teck and Universal Implants. Dr. Estrin served as Senior Vice President - R&D and Regulatory Affairs for Discovery Pharmaceuticals Inc., a development stage company with a unique product for marking tumors invisibly on patients. He is a cofounder of the company. Dr. Estrin was also President & Chief Executive Officer of Réma, L.L.C., a new cosmetic company he cofounded that has developed a product that temporarily removes fine lines in a matter of a few minutes. He currently serves as a member of the Board of Maven Technologies. Maven has developed a label-free detection technology that allows low to high density multiplexing for real-time or end-point analysis.


Dr. Estrin's 17 years of experience in charge of scientific regulatory programs for the Cosmetic, Toiletry and Fragrance Association (CTFA) provided him with a thorough understanding of the safety, labeling, technical and environmental issues facing this industry. While at CTFA, Dr. Estrin:

  • conceived and edited the Cosmetic Ingredient Dictionary, now recognized internationally as the most comprehensive source of information about cosmetic ingredient nomenclature in the world.
  • developed industry Technical Guideline program cited by the FDA as the major reason it did not impose Good Manufacturing Practices regulations on the cosmetic industry.
  • helped Establish the Cosmetic Ingredient Review program and the Johns Hopkins Center for Alternatives to Animal Testing.
  • Developed the Compendium of Cosmetic Ingredient Composition to assist manufacturers in buying quality raw materials.
  • and his excellent staff were responsible for ensuring that CTFA's $10 million color additive testing program proceeded expeditiously and according to the highest standards. He coordinated most of the regulatory submissions and presentations to the FDA.
  • developed training programs for plant personnel in microbiology and quality assurance.
  • Developed and edited unique interdisciplinary book, The Cosmetic Industry: Scientific and Regulatory Foundations,(Marcel Dekker, 1984).

Dr. Estrin's recent cosmetic experience includes cofounding two cosmetic companies and engaging in product development, and arranging for manufacturing and distribution. He also traveled to China to arrange for possible manufacture and for distribution of the products for Chantal Pharmaceutical Corporation and served on its Board from 1996-1997. His current book, the Cosmetic Industry-Cosmetic Regulation in a Competitive Environment was published by Marcel Dekker, Inc. in 2000.


Dr. Estrin has received the cosmetic Industry's two highest honors, the Maison deNavarre Medal Award and the CIBS Award for "an outstanding career of contributions to the cosmetic industry." He also received the Special Recognition Award from the Regulatory Affairs Professional Society. Earlier in his career, Norm received the Chemists' Club Award "in recognition of outstanding dedication to the teaching of chemistry".

He served on the Board of Trustees of the National Health Museum (under C. Everett Koop, M.D.) from 1991 to 2000, the Editorial Advisory Board of the FDA Regulator & Quality Advisor, among other Boards. Norm also previously served on the Board of the National Committee for Clinical Laboratory Standards, the Board of Editors of Regulatory Affairs Focus and the Regulatory Affairs Journal.

1990 to Present President, ESTRIN CONSULTING GROUP, LLC
1997 to Present President & COO, Réma, LLC
1991 to Present Senior V.P.-R&D and Regulatory Affairs, DISCOVERY PHARMACEUTICALS INC.
1985 to 1990 Vice President-Science & Technology, HEALTH INDUSTRY MANUFACTURERS ASSOCIATION
1968 to 1985 Senior Vice President - Science, COSMETIC, TOILETRY AND FRAGRANCE ASSOCIATION


1968 Ph.D. Physical Organic Chemistry (Florida State University)
1962 M.S. Organic Chemistry (New York University)
1959 B.S. Chemistry (Brooklyn College)
1992 Regulatory Affairs Certification
1980 8 year program covering all aspects of association management, Institute for Organization Management, U.S. Chamber of Commerce



Cosmetic Regulation in a Competitive Environment; N.F. Estrin and J.A. Akerson, editors (Marcel Dekker, 2000)

The Medical Device Industry: Science, Technology and Regulation in a Competitive Environment; NF Estrin, editor (Marcel Dekker, 1990).

Safe Handling of Biological Contaminated Medical Devices Sourcebook, Daniel, Olsen and Estrin, editors (HIMA, 1988)

AIDS Sourcebook, Volume1,2, Olsen, Estrin, Daniel and Krupa, editors (HIMA, 1988)

The Cosmetic Industry: Scientific and Regulatory Foundations,NF Estrin, editor (Marcel Dekker, 1984)

CTFA Compendium of Cosmetic Ingredient Composition, Volumes 1-4, NF Estrin, editor (CTFA, 1983, 1976, 1974, 1972, 1971)

The Cosmetic Ingredient Dictionary, NF Estrin, editor (CTFA 1983, 1977, 1973)

CTFA Technical Guidelines, NF Estrin, editor (CTFA, 1981, 1974)

CTFA Standards, Volumes 1-6, (Specifications, Methods, Spectra and Descriptions), NF Estrin, editor, 1971