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Food and Drug Administration regulation

statute

disinfectant Food and Drug Administration regulation

in vitro diagnostics Food and Drug Administration code

Food and Drug Administration food packaging regulation

FDA food labeling regulation

Food and Drug Administration food regulation

21 CFR Part 11

Food and Drug Administration National Drug Code

FDA limulus amebocyte lysate test regulation

Food and Drug Administration cosmetic regulation

Food and Drug Administration CFR-21 part 175

Food and Drug Administration drug packaging regulation

color additive regulation

drug regulation

Food and Drug Administration new drug code

FDA medical device regulation

food regulation

international food statute

Food and Drug Administration compliance

reference daily value

package-food product interaction

food biotechnology

Food and Drug Administration

pre-approval inspection

Drug Information Association

Expert in Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry
He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11. He has developed advertising campaigns, written copy for advertisements and managed the creative development of ... See full profile

Montana (MT), USA

Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due ... See full profile

Virginia (VA), USA

Expert in Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new ... See full profile

Florida (FL), USA

Expert in Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, ... See full profile

Nevada (NV), USA

Expert in Physical Chemistry of Food & Drugs
Food chemistry; food drying. Expert is a recognized authority in the physical chemistry of the stability of dry and semi-moist systems including foods, drugs, and biologies. His major research areas deal with the effect of temperature ... See full profile

Minnesota (MN), 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

Expert in Food Ingredient, Dietary Supplement, Seafood, FDA
In his current role, Expert provides regulatory consulting to the food, food ingredient, and dietary supplement, color, cosmetic and related industries. He also is an U.S. agent for foreign color manufacturers, and the HACCP Program Director. See full profile

Virginia (VA), 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 Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action in a ... See full profile

Michigan (MI), USA

Expert in FDA Medical Device Quality Systems, Governmental Registration Process, International Business, GMP
As an ex-FDA official for over 21 years (not only as a experienced investigator/analyst, but also when he acted as field and HQ compliance officers during details to these offices), Expert is highly familiar with FDA compliance. He retains this knowledge ... See full profile

Pennsylvania (PA), USA

Expert in FDA, Food Regulations, Products with Health Claims
Expert began consulting in February 1999, after a 35-year career with the FDA. She has considerable expertise in the regulation of food products, having served as Director of the Division of Programs and Enforcement Policy in the Office of Food Labeling ... See full profile

Virginia (VA), USA

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

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 GMPs for Drugs, Devices, Biologics
The primary focus of Expert's career has been to establish documentation systems that support the quality assurance requirements of GMP and ISO regulations for product development and commercial manufacturing. See full profile

Minnesota (MN), 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 FDA Labeling Requirements: Foods and Dietary Supplements
Expert has written a book on food and dietary supplement labeling. He is the author of valuable reference books that provide a comprehensive guide designed to aid in understanding FDA labeling requirements as they apply to foods and dietary supplements. See full profile

Virginia (VA), USA

Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and ... See full profile

Illinois (IL), USA

Expert in FDA Audit, FDA Regulation, GMP
Expert has more than 41 years of inspection experience to offer. He served 32 years with FDA and another 9 years conducting audits and serving as a consultant of FDA regulated industries throughout the United States for AAC/Kendle before joining EAS as a ... See full profile

Virginia (VA), USA

Expert in HACCP Audits, HACCP Plans, and HACCP Training Courses
If you are looking for an internationally recognized expert in Seafood HACCP, with 35 years of FDA experience and more than 6 years of consulting experience, you will be pleased to know that this consultant is available to assist your firm develop and ... See full profile

Virginia (VA), USA

Expert in FDA Regulations, Labeling and Compliance; Medical Devices, Medical Products Liability
Expert has over 35 years medical device industry experience actively involved in the design, development, manufacture, FDA regulation compliance, labeling, and quality control of medical devices. His expertise includes implementation of corporate ... See full profile

Minnesota (MN), USA

Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
I am a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; I acquired more than 21 years' experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects ... See full profile

Québec, Canada

Expert in Manufacturing and Distribution in Food, Beverage and Nutitional Supplement Industries
Expert has extensive expertise in the Food, Beverage and Nutritional Supplement industries in the areas of manufacturing, suppy chain, planning, packaging, warehousing, distribution and custmer service from the floor level through Executive Management. See full profile

South Carolina (SC), 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 Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst, an editor ... See full profile

Virginia (VA), USA

Expert in Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). See full profile

Minnesota (MN), USA