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Experts in Food and Drug Administration National Drug Code| The following experts are available as Food and Drug Administration National Drug Code consultants and Food and Drug Administration National Drug Code expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Food and Drug Administration National Drug Code -
An FDA regulation requiring that all prescription drugs be imprinted with a code number on the label. Synonyms: FDA National Drug Code |
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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 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 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 | | | |  | | Expert in Pharmaceutical Consulting
Expert served with the FDA for 20 years. He provided advice and assistance on FDA operations and regulatory policy. Other duties included Warning Letter and FDA-483 reviews and advice, Regulatory Application reviews, advice and drafting; ... See full profile | | Virginia (VA), 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 FDA Regulatory Consultant for Medical Devices, Cosmetics, and OTC Drugs
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 ... See full profile | | Maryland (MD), 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 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 Regulatory Compliance Auditing, Training; FDA NDA/ANDA and DEA QA and Drug Inspections, Approvals
Expert is an internationally recognized authority on GMP and ISO auditing. In 1984 he authored the GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. In use by over 8000 companies worldwide, and translated into ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Pharmaceutical Development, Analytical Methods, Method Validation and GMP/Part 11 Compliance
Expert has been involved with cGMPs since their re-release in March 1979. For 7 years during his tenure at Roche he was Compliance and Training Officer for the Technical Development and Kilo Lab Departments, and developed schemes by which the Pilot Plant ... See full profile | | New Jersey (NJ), 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 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 Pharmacoepidemiology, Pharmacoeconomics, Epidemiology, FDA, Drugs, Education
Expert is one of the leaders in the field of pharmacoepidemiology. He has extensive experience consulting on issues of applying epidemiological principles to the risk/benefit assessment of drugs. As Director of Global Pharmacoepidemiology and Health ... See full profile | | Missouri (MO), USA | | | |  | | Expert in Software Quality & Life Cycle, ISO 9000 Standards, Software Regulatory Issues, etc.
Ms. D. Expert has extensive expertise with the maintenance, re-engineering, and reuse of computer software. She has maintained large telecommunications systems and established processes that resulted in effective provision of ... See full profile | | New York (NY), 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 | | | |  | | Expert in Pharmaceutical Research and Product Development, Formulation and Analysis
Expert has spent nearly 12 years at Expert's Consulting Firm, teaching undergraduate and graduate courses in controlled drug delivery systems, pharmaceutical solutions, drug stability, drug diffusion and pharmaceutical rate processes. See full profile | | Pennsylvania (PA), 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 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 Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition of ... See full profile | | New Jersey (NJ), 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 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 Clinical Trial and Drug Safety in New Drug Development and Marketing/Commercialization
Expert has a working knowledge of ICH guidance related to patient protection and relevant US laws. As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and ... See full profile | | New Jersey (NJ), 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 | | |  | | >> Next 25 Experts
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