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 Expert  713595

Expert in FDA Regulatory Consultant for Medical Devices, Cosmetics, and OTC Drugs


Available for your Consulting and Expert Witness Needs

Maryland (MD)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert is a renowned authority in the cosmetic, OTC drug and medical device industries. He has had over 40 years of experience dealing with regulatory, scientific, and technical issues for FDA regulated industries. He served as Senior Vice President – Science of the Cosmetic, Toiletry, and Fragrance Association (CTFA, now the Personal Care Products Council) and the Health Industry Manufacturers Association (HIMA, now AdvaMed), as Vice President Science & Technology, directing scientific and technical programs. Expert received the Society of Cosmetic Chemists' Maison DeNavarre Medal Award for “Outstanding Contributions to the Art and Science of Cosmetics” and the CIBS Award from the CTFA for Outstanding Scientific Contribution and Service to the Cosmetic Industry, and also the Regulatory Affairs Professionals Society's Special Recognition Award.

MEDICAL DEVICES. Expert (he prefers "Norm") is Managing Partner of Expert's Firm. For two decades, Expert's Firm has represented the business, regulatory, technical and educational interests of manufacturers of medical device, OTC drug, and cosmetic products. Expert's Firm assists device companies in the preparation or 510(k) and pre-IDE submissions to the U.S. Food and Drug Administration (FDA). He works with companies to develop regulatory strategies and presentations to the FDA. Expert's Firm also helps ensure that company registrations with the FDA are current and helps develop regulatory strategies for interacting with the FDA.

COSMETICS AND OTC DRUGS. Expert's Firm helps cosmetic, and OTC drug companies with regulatory issues, such as reducing regulatory risks in developing cosmetic ingredient labeling, and in navigating the OTC review process. Expert has also been called upon to represent companies as an expert witness. Expert's Firm also assists medical device and OTC drug companies in registration and listing with the FDA and Expert acts as the U.S. Agent for foreign companies in accordance with FDA regulations. Expert has had seventeen years of experience in charge of scientific regulatory programs for the Cosmetic, Toiletry, and Fragrance Association (Now, the Personal Care Products Council). That has provided him with a thorough understanding of the safety, technical, and environmental issues confronting this industry. Completion of two books for Marcel Dekker, Inc. on cosmetic regulation and current cosmetic consulting at Expert's Firm has kept him current on industry issues. He has also conceived and edited a number of other major textbooks, including the International Cosmetic Ingredient Dictionary and Handbook. Expert helped establish the Cosmetic Ingredient Review program and the Johns Hopkins Center for Alternatives to Animal Testing. He was a member of the Board of Trustees of the National Health Museum (1991-2000) and served on the Board of Directors of Chantal Pharmaceutical Corporation (1996-1997), a public company.

COSMETIC COLOR ADDITIVES. While at the Cosmetic, Toiletry, and Fragrance Association, Expert and his staff were responsible for ensuring that CTFA's $10 million color additive testing program proceeded in a timely way and according to the highest scientific standards. He coordinated most of the technical and regulatory submissions and presentations that were made to the FDA on the issue.

For a decade, Expert's firm, Expert's Firm (ECG) has represented the business, regulatory, marketing, technical and educational interests of manufacturers of medical device, drug and cosmetic products. In particular, ECG assists companies in the preparation or 510(k) and pre-IDE submissions to the U.S. Food and Drug Administration (FDA). ECG also ensures company registrations with the FDA are current and helps develop regulatory strategies for interacting with the FDA. In addition, ECG helps cosmetic, and OTC drug companies with regulatory issues, such as reducing regulatory risks in developing cosmetic ingredient labeling, the OTC review process . Expert has also been called upon to represent cosmetic companies as an expert witness. ECG also assists medical device and OTC drug companies in registration and listing with the FDA and Expert acts as the U.S. Agent for these companies.
ECG assists manufacturers of biomedical insrumentation in meeting FDA regulatory requirements, such as for 510(k) and Pre-IDE submissions.
While at CTFA, Expert coordinated a safety testing program to support color additive petitions to the FDA as required by FDA regulations.
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color additive regulation

Expert received the cosmetic industry's two highest awards for outstanding contributions to cosmetic science. He started his career as a hair dye chemist at Clairol. He continued his work for the cosmetic industry at its trade association, the Cosmetic, Toiletry and Fragrance Association (CTFA).
As Senior Vice President for the Cosmetic, Toiletry and Fragrance Association, Expert worked closely with the FDA on issues such as the safety, quality and labeling of cosmetic products. He coordinated more than 10 million dollars of color additive safety testing to support continued use of color additives in foods, drugs and cosmetics. He similarly coordinated testing of cosmetic ingredient impurities, such as nitrosamines, and helped minimize microbial contamination through coordinating committees producing appropriate guidelines.
ECG assists cosmetic companies in complying with Food and Drug Administration cosmetic regulations.

While at CTFA, Expert established committees to develop Technical Guidelines, which made further Food and Drug Administration cosmetic regulation through GMPs unnecessary.

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Food and Drug Administration cosmetic regulation

ECG assists medical device manufacturers in complying with Food and Drug Administration medical device regulations.

Through his role as Vice President for Science & Technology of the Health Industry Manufacturers Association (now AdvMed), Expert has interacted with the FDA on many policy issues affecting the medical devices industry, such as AIDS, ethylene oxide safety and international regulation. He also coordinated committees and task forces to deal with product specific issues, such as involving condoms, gloves, breast implants, etc.

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FDA medical device regulation

ECG assists companies in preparing Pre-IDE submissions to the FDA in compliance with the investigational medical device exemption regulation.
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investigational medical device exemption regulation

ECG assists companies in complying with medical device regulations.
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medical regulation

ECG assists manufacturers of over-the-counter cosmetics in complying with FDA regulations.
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over-the-counter cosmetic

ECG assist manufacturers of over-the-counter drugs in complying with FDA regulations.
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over-the-counter drug

Expert received his doctorate in physical organic chemistry under Dr. DeLos DeTar for the synthesis and study of optically active sequence polypeptides.
ECG assists manufacturers of skin care products in complying with FDA regulations. In addition, Expert has received a patent for a new anti-wrinkle skin care product.
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skin care product

ECG helps companies devise labeling to minimize the risk that the FDA will classify their products as cosmetic-drugs rather than as cosmetics. The former category is subject to both cosmetic and drug regulatory requirements.
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cosmetic labeling

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drug labeling requirement

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drug regulation

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labeling regulation

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510(k) document


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland;  Frederick, Maryland;  Gaithersburg, Maryland;  Bowie, Maryland;  Richmond, Virginia;  Alexandria, Virginia;  Wilmington, Delaware;  and Lancaster, Pennsylvania.

Often requested
with this expert:

FDA Regulations, Labeling and Compliance; Medical Devices,...
FDA Regulations, Drugs, Cosmetics
Personal Care Products
Personal Care Products

Education:
Year   Degree   Subject   Institution  
1968   Ph.D.   Physical Organic Chemistry   Florida State University  
1962   M.S.   Organic Chemistry   New York University  
1959   B.S.   Chemistry   Brooklyn College  

Work History:
Years   Employer   Department   Title   Responsibilities

1990 to

 

(Undisclosed Consulting Company)

 


 

ManagingPartner

 

Expert assists medical device, cosmetic, and drug companies in developing regulatory strategies, and preparing device submissions, cosmetic/OTC drug labeling review, as well as serving as a liaison with the Food and Drug Administration (FDA).

1991 to 2002

 

Discovery Pharmaceuticals, Inc.

 

R&D and Regulatory Affairs

 

Senior Vice President

 

Discovery Pharmaceuticals, Inc. was a development-stage company with a patented device to mark sites for radiation treatment with a dye visible only by UV light.

1985 to 1990

 

Health Industry Manufacturers Association

 


 

Vice President of Science & Technology

 

Expert managed an extensive scientific and technical committee structure, a staff of eight and a budget of $500,000.

1968 to 1985

 

Cosmetic Toiletry & Fragrance Association

 


 

Senior Vice President of Science

 

He created and managed scientific committees to develop scientific programs and books important to the safety, quality, and regulation of cosmetics.

1961 to 1963

 

Clairol Research Laboratories

 

R&D

 

Chemist

 

Expert researched, synthesized, and purified potential hair dyes.


Career Accomplishments:
Associations/Societies

Expert is a member of the Regulatory Affairs Professional Society and is a life-member of the American Society of Association Executives.

Licenses/Certifications

He was Regulatory Affairs Certified by the Regulatory Affairs Professional Society and received a certificate for completion of an eight-year program on association management.

Professional Appointments

Expert served as a member of several boards, including the Board of Directors for Discovery Pharmaceuticals (1992-2002), Chantal Pharmaceutical Corporation (1996-1997), the National Committee for Clinical Laboratory Studies (1988-91), the Board of Trustees for the National Health Museum (1991-2000), the Board of Trustees for the Institute for Advancement of Medical Communication (1989-1995), and the Board of Editors of Regulatory Affairs Focus (1995-1996).

Awards/Recognition

Expert is a Fellow of the Society of Cosmetic Chemists. He received the Special Recognition Award from the Regulatory Affairs Professional Society and has won the cosmetic industry's two highest honors, the Maison deNavarre Medal Award and the CIBS Award for "an outstanding career of contributions to cosmetic science and to the cosmetic industry."


Publications:
Publications and Patents Summary

Expert has created and edited several textbooks on medical device and cosmetic regulation, and the CTFS International Cosmetic Ingredient Dictionary. He received a patent for a new "instant" wrinkle-removing formula.

Selected Publications and Publishers  
 - Marcel Dekker  
 - Ibid  
 - Marcel Dekker, NY and Basel  
 - CTFA  

Consulting Services:
Selected Consulting Examples:
  • Expert gave a presentation to a major Swedish diagnostic company on regulatory options in the U.S. and gave a presentation to a Swedish biotechnology company on regulatory and business strategy.
  • He provided guidance to a medical device company in responding to FDA concerning a 510(k) submission.
  • Expert was an invited expert by the National Research Council (National Academy of Sciences) to teach a week-long course in Thailand to the Ministry of Health on cosmetic and medical device regulation. He also addressed the Ministries of Health in Beijing and Singapore on regulatory issues.
  • He provided training and cosmetic labeling guidance for six years to a large South American company to reduce its regulatory risks in exporting to the USA. He also negotiated with U.S. Customs on detained products.
  • Expert currently serves as an expert witness for a Fortune 500 company on an alleged cosmetic ingredient safety issue.
Recent Client Requests:
  • Fda skin care packaging expert for consulting on fda regulations for skin care products packaging.
  • Expert in 510k submission for a wound dressing gel to assist with FDA approval.
  • FDA expert for consulting on a Label review project for new herbal product
  • 510k expert for consulting on 510k application for class II medical device.
  • FDA expert for consulting on FDA Product registration.
  • Cosmetics expert for consulting on the effect of vitamin A in cosmetic line.
  • OTC expert for consulting on new product launch.
  • Expert in surface contamination found on/in syringe components.
  • Expert for consulting on FDA.
  • FDA labeling expert for dietary suplements for consulting on verifying claims with the FDA.
  • 510k expert for consulting on FDA Approval of Medical Device.
  • Over-the-counter expert for consulting on OTC personal care products.
  • Expert in quality systems and auditing for FDA regulatory affairs.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
Expert serves an an expert witness for cosmetic and toiletry companies in alleged personal injury cases.
Recent Litigation Client Requests:
  • Fda labeling warning expert for consulting on phospho soda litigation.
  • Expert for consulting on anti-aging cream false claims
  • Expert witness MHRA for consulting on EMA/MHRA.
  • Cosmetic expert Firms for consulting on patent infringement matter.
  • Expert for consulting on FDA labeling.
  • Expert fda labelling for consulting on Correcting Ingredient Label.
  • FDA regulatory expert for consulting on OTC skin lightening cream product liability case.
  • FDA expert witness for consulting on an atypical antipsychotic..
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1997 to 1997   Hong Kong   Expert assisted a cosmetic company in finding distributors in Asia and in meeting with regulatory authorities in Taiwan.

Market Research:
He met with major cosmetic companies to develop marketing agreements for a wrinkle-removing product for which he holds a patent.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Expert developed and participated in training seminars on how to prepare medical device submissions to the FDA. He is currently presenting webinars on reducing regulatory risks in developing labeling claims at the cosmetic/OTC drug interface.

Other Skills and Services

Expert has assisted companies in developing business plans and in obtaining venture capital. He has assisted law firms as an expert in responding to consumer complaints of harm due to use of hair products. He also has assisted a cosmetic company in finding distributors in Asia. Expert helps companies communicate effectively through review and editing of draft presentations and business plans. Expert served on the Board of Trustees and on the Executive Committee of the National Health Museum under its Chairman, former Surgeon General C. Everett Koop. He was also on the capital development committee and chairman of the bylaws committee.


 

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