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Expert Quote | | |  | | 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 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 | | | |  | | 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 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 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 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 Compliance, Pharmaceutical New Products, Management Training, Seminars, Inspections, Audits
During his employment with the Food and Drug Administration, Expert received five grade promotions, with his last position being that of Director of the Science Branch of the Philadelphia District. Expert's area of responsibility included all the ... See full profile | | Georgia (GA), USA | | | |  | | 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 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 Food Packaging, Food Safety, Food Quality, Food Additives; FDA Compliance, Dairy, JECFA, WHO & FAO
Food packaging; food chemistry; food safety. Expert is an expert in food packaging technology, materials, processes, and toxicology. His primary area of expertise lies in the overlapping relationships between packaging ... 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 Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also ... See full profile | | California (CA), 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 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 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 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 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 Pharmaceutical/Biotech Clinical Trials, Regulatory, R&D, Mergers & Acquisitions, Trends, Outsourcing
Expert is Director of Regulatory Affairs and Clinical Trials managing $3.6 billion at at a pharmaceutical company in New York, NY. His expertise is in managing and deploying outsource/insource teams worldwide for multiple clinical trials and ... See full profile | | Michigan (MI), 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 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 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 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 OTC Drugs, Generic Drugs, New Drugs and General Drug Regulations and FDA Requirements
During his tenure with FDA since 1991, Expert served in the Policy and Guidance Branch of the Center for Drug Evaluation and Research (CDER) with responsibility for the development and interpretation of the Current Good Manufacturing Practice ... See full profile | | Virginia (VA), USA | | |  | | >> Next 25 Experts
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