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over-the-counter drug regulation


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active pharmaceutical ingredient


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Food and Drug Administration


Food and Drug Administration regulation


over-the-counter drug


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.  ORC 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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Join our distinguished experts for over-the-counter drug regulation jobs, projects and consulting opportunities.

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Experts in Over-the-Counter Drug Regulation
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Expert in Pharmaceuticals & healthcare in Brazil: entry strategy, market evaluation & BD
Expert has ran 6 pharma & healthcare businesses as General Manager/CEO/President in his 40 years in Brazil ranging from subsidiaries of US, German, UK & Latin American labs to local start ups. Businesses covered Rx & hospital products, OTCs & consumer ... See full profile


Expert in FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. 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


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 Regulated and Hazardous Materials Auditing, Compliance, Programs, Processes and Training
Expert has utilized his scientific and logistics experience to analyze and consult regarding materials that were thought to be difficult or "impossible" to produce or ship in normal modes commerce. With an intimate knowledge of material and production ... See full profile

South Carolina (SC), USA

Expert in Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training ... See full profile

Alabama (AL), USA

Expert in Clinical Development
Expert is a Clinical Development executive with over 18 years of expertise and experience in the pharmaceutical industry. Proven track record of successfully managing large budgets with multiple programs and taking drugs from Phase I to Health ... See full profile


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 Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
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

Berkshire, United Kingdom

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 Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices
Expert was a California Food & Drug Investigator for 25 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. See full profile

California (CA), 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


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 Polymer Chemistry and Processing Related to Softgel Technology, Pharmaceuticals, and Medical Devices
Expert worked for over 15 years in biomedical polymer research, first in contract research to synthesize, process, and characterize biocompatible polymers, and then in medical device R&D for Johnson & Johnson where he was responsible for polymer ... See full profile

Florida (FL), USA

Expert in Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological ... See full profile

New Jersey (NJ), USA

Expert in Pharmaceutical and Other Healthcare Management
Expert has had responsibility for conducting market studies and assessments in various countries and has commissioned qualitative studies in the antiviral field. He has coordinated market reviews in anti-epileptics, AIDS and the OTC sector. See full profile

D. F., Mexico

Expert in Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination ... See full profile

Minnesota (MN), USA


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