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Related Expert Areas

  

over-the-counter drug regulation

  

product regulation

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active pharmaceutical ingredient

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drug label comprehension research

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pharmacodynamics

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over-the-counter topical drug product development

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over-the-counter drug product development

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prescription drug

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Food and Drug Administration cosmetic regulation

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Food and Drug Administration

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Food and Drug Administration regulation

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over-the-counter drug

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Good Manufacturing Practice

 

Experts in Over-the-Counter Drug Regulation

The following experts are available as over-the-counter drug regulation consultants and over-the-counter drug regulation expert witnesses.  Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Over-the-Counter Drug Regulation - A regulation relating specifically to over-the-counter drugs, especially one published by the FDA.

Synonyms:  OTC drug code, OTC drug law, OTC drug ordinance, OTC drug regulation, OTC drug rule, OTC drug statute, OTC pharmaceutical law, OTC pharmaceutical regulation, OTC pharmaceutical rule, over-the-counter drug code, over-the-counter drug law, over-the-counter drug ordinance, over-the-counter drug rule, over-the-counter drug statute, over-the-counter pharmaceutical law, over-the-counter pharmaceutical regulation, over-the-counter pharmaceutical rule

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1 to 25
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Experts in Over-the-Counter Drug Regulation
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Expert in Personal Care Products
Cosmetic product; toiletry; antiperspirant; deodorant. Expert has over 40 years of experience in managing the product development of cosmetics, toiletries, and over-the-counter drugs. He was involved with the development of name brand ... See full profile

New Jersey (NJ), USA

Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer's and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic's regulations. See full profile

Quebec, Canada

Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. See full profile

Netherlands

Expert in FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and ... See full profile

California (CA), USA

Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), USA

Expert in HIPAA, Sunshine Act, Medical, Advisory Board, Brand, Generic, Commercial Pharmaceuticals
Expert is currently Associate Senior Counsel in the U.S. Legal Department of a top-20 pharmaceutical company, where he has worked since 2008. He provides proactive legal support to product teams and client groups across the organization and ... See full profile

New Jersey (NJ), USA

Expert in Product Development, Product Safety, Product Testing, Claims Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. See full profile

Arizona (AZ), USA

Expert in FDA Litigation, Regulatory Compliance and Strategy & FDA Regulations
Expert offers your company his 33 years of experience as an Attorney in the Office of the Chief Counsel of the FDA, and 8 years as a consultant to FDA-regulated industries. He provides clients with a wide-range of regulatory consulting services. See full profile

Virginia (VA), USA

Expert in Hatch-Waxman patent litigation, CMC Pharma Dev Issues, Preformulation/Formulation, Regulat-Reports
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal ... See full profile

Florida (FL), USA

Expert in Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product ... See full profile

Florida (FL), USA

Expert in Custom Market Research, Pharmaceutical Industry
With more than 10 years of research experience, the expert has particular expertise in the pharmaceutical industry including Rx and OTC products. Expert has broad experience in FDA-related research as well such as label comprehension research in ... See full profile

New York (NY), USA

Expert in Phytochemistry, Pharmacognosy, Biological Testing, Natural Product Extraction, Regulatory Approval
Expert specializes in phytochemistry and pharmacognosy where he helped develop the world-first Herbal Medicine BSc degree. He has over 15 years consulting experience to the natural products industry and works with a network of academics and ... See full profile

Essex, United Kingdom

Expert in Design and Conduct of Clinical Trials for Oral Healthcare Products
Expert is a trained periodontist with a career in both academics and industry. He was the senior director of dental affairs and new technology at Warner-Lambert (later Pfizer) consumer health products R&D for close to 15 years. See full profile

New Jersey (NJ), USA

Expert in Pharmaceutical Product Development, Drug Safety, Regulatory Affairs, Due Diligence
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. See full profile

Northamptonshire, United Kingdom

Expert in Health and Personal Product Development
Expert brings 40 years of experience directing the development and evaluation of new and improved pharmaceutical and personal care products to assist you in managing the technical aspects of your business. In addition to developing several ... See full profile

New Jersey (NJ), USA

Expert in FDA Regulations, Drugs, Cosmetics
Antiperspirants. a major portion of Expert's career has been involved in research, development, and testing of antiperspirant (A-P) products. He holds numerous patents in this area, has been on industry advisory panels on toxicology ... See full profile

Florida (FL), USA

Expert in Plant Products, Tissue Culture
Plant tissue culture; medicinal plants. Expert has devoted the majority of his research effort over 30 years to the in vitro growth of plants of interest as drugs (such as morphine, steroids, and cardiac drugs), agricultural ... See full profile

Minnesota (MN), USA

Expert in CRO in Medicinal Chemistry, Pharmaceutical Chemistry, API, CRAMS, Speciality Chemicals, Training
Expert received his PhD in synthetic organic chemistry from the University of Hyderabad. He has 2 years of post-doctoral experience in synthetic and physical organic chemistry from University of Houston. He also worked on chiral polymers and energetic ... See full profile

India

Expert in Neuropharmacology, Intoxication, Drug Abuse, Disability, Poisoning, Pharmacological Pain Management
From a background in behavioural pharmacology of opiate and non-opiate analgesic drug development and cognition-related drug effects, in both university and pharmaceutical industry basic and clinical research, Expert has thirty post-doctoral years of ... See full profile

Tennessee (TN), USA

Expert in Aesthetic and Cosmetic Medicine
After finishing his undergraduate in 1992, Expert obtained three separate diplomas including in Child Health (DCH), in Dermatological Science (DDSc) and in Genito-Urinary Medicine (Dip GUM) in 1996. He received his PhD from the University of ... See full profile

South Glamorgan, United Kingdom

Expert in Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, ... See full profile

Kent, United Kingdom

Expert in Pharmaceutical, Cosmetics and Nutritional Supplements Product Development and Production
Expert has applied his pharmaceutical and cosmetic technology backgrounds to the development of fast acing and very effective after shaves especially aftershaves for problem skin. He has formulated soothing and conditioning aftershaves with natural and as ... See full profile

Massachusetts (MA), USA

Expert in Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert's primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet ... See full profile

Florida (FL), USA

Expert in Intellectual Property Law, Patent Law; Industries: Biotech, Pharmaceutical, Life Sciences
Expert's Ph.D. thesis research concerned the plasma proteins, especially fetuin. He completed postdoctoral research fellowships at Harvard Medical School / NIH (Alzheimer's disease, tau gene, genomic cloning), Johnson & Johnson (skin diseases, ... See full profile

Florida (FL), USA

Expert in Pharmaceutical Regulatory Affairs and Quality Compliance
Expert provides regulatory consulting services to the pharmaceutical, biologics, medical device and food industry to assure compliance with U.S. Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), ... See full profile

Indiana (IN), USA

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