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Experts in Food and Drug Administration Drug Registration| The following experts are available as Food and Drug Administration drug registration consultants and Food and Drug Administration drug registration expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Food and Drug Administration Drug Registration -
The submission of necessary studies and other documentation to the Food and Drug Administration to seek approval for the marketing of a drug. Synonyms: FDA drug registration |
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(of 22) | | | Experts in Food and Drug Administration Drug Registration |
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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 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 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 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 Psychopharmacology in Historical Perspective, Regulatory Behavior, etc.
Over the past 20 years he has done extensive research on the history of drug discovery, drug development, drug registration, and the use of psychopharmaceuticals in medical practice. Among the documents he has collected are the virtually complete set of ... See full profile | | Wisconsin (WI), 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 Food Science & Technology
Expert is currently a Food Science & Technology Consultant and employed in the private food sector in Jordan. He is an active member in many technical committees for food in JFDA, JISM and Ministry of Environment, and the Ministry of Agriculture. See full profile | | Jordan | | | |  | | 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 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 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 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 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 Statistics and Data Management; Pharmaceutical Industry
Expert has vast experience in the field of pharmaceutical development. He has been responsible for managing all quality laboratories, and product quality assessment and release to market. He has also evaluated process and product data for 54 drug ... 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 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 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 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 New Drug Development and Approval
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to ... See full profile | | Arizona (AZ), 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 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 Pharmaceutical Chemical Process R&D, Manufacturing, Disaster Recovery, Software Design
As the IT Manager for a major pharmaceutical company Expert has expertise in selection and validation of document management systems, inventory control, instrument calibration systems, as well as computer software utilized in the pharmaceutical ... See full profile | | New York (NY), USA | | | |  | | Expert in Pharmaceutical and Biopharmaceutical Product Development, Formulation and Stabilization Technology
Expert has fifteen years of experience in product development, formulation development, and drug delivery for pharmaceutical and diagnostic industries. She has thoroughly developed skills in research planning, product formulation, and analytical ... See full profile | | Ohio (OH), USA | | |  |
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