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Governmental Registration Process Experts

The following experts are available as governmental registration process consultants and governmental registration process expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Governmental Registration Process - The submission of necessary studies and other documentation to a governmental agency such as the EPA or FDA, to seek approval for the marketing of commodities such as food or feed additives, chemicals, drugs, or medical devices.

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Governmental Registration Process Experts
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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 Public Relations and Government Relations
Expert is Principal and Chief Magnifier in Expert's Firm. He is the driving force behind Expert's Firm' success. He is an experienced event planner, public and media relations expert. He is able to call upon close to thirteen years of ... See full profile

Quebec, Canada

Expert in Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA ... See full profile

Minnesota (MN), USA

Expert in Medical Device Product Development; Machine Design; Biomedical Engineering
He performed research on adding an antimicrobial agent to a silicone rubber part molded using LIM. Research included materials, methods of molding, color changes, and effect of additive to biocompatibility. His library contains many materials available ... See full profile

New Hampshire (NH), USA

Expert in Anesthesiology, Pain Management, Biomedical Engineering, Electrical Engineering
Expert is currently developing new medical devices as part of his research. In addition, he has several medical device patents. He has also done significant defense and plaintiff legal work regarding medical devices and medical malpractice. See full profile

New Jersey (NJ), 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 Medical Devices; Product Development, Manufacturing, Marketing, Business practices, IP
Expert has been the CEO or chairman of 7 medical device companies in 4 countries - 4 public, 3 private, and has been a member of the Board of Directors of 8 companies. He is an expert in all areas of general and specific management of a medical device ... See full profile

Minnesota (MN), USA

Expert in Medical Device Manufacturing & Biocompatible Material: Orthopaedic Devices, Cardiology, Review, etc.
Expert has been actively involved in orthopaedic, cardiology and urology development projects for a number of years. All of these projects have relied upon and require biocompatible materials. As such he has developed an excellent understanding of the ... See full profile

NJ, Israel

Expert in Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
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 clinical use. Expert is an expert in drug clinical development from planning to protocol design, ... See full profile

Massachusetts (MA), USA

Expert in Fructans Processing and Agronomy
After having prepared a part of a processing plant to produce Bio-ethanol from molasses, Expert did three years of research on bio-ethanol production from feedstock producing carbohydrates, ready to be fermented; and from feedstock producing starch to be ... See full profile

Washington (WA), USA

Expert in Expert Witness Services, Product Development, product Design, Project Management
Expert has been directly involved in the development of medical devices and their manufacturing processes for nearly forty years. These included ten years of responsible positions in industry, as well 30 years as the president of ... See full profile

Washington (WA), USA

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into ... See full profile

Delaware (DE), USA

Expert in Infectious Diseases, Infection Control, Epidemiology, Public Health, and Pediatrics
Expert was an author on the Centers for Disease Control and Prevention (CDC) Guideline for Prevention of Transmission of M. tuberculosis in Healthcare Settings and the WHO Guideline for Prevention of M. tuberculosis Transmission in ... See full profile

South Carolina (SC), 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 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 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, packaging migrants, and toxicology. His primary area of expertise lies in the overlapping relationships ... See full profile

New York (NY), USA

Expert in Pharmaceutical and Biomedical Business Development, Technology Evaluation and Licensing
Expert is the founder and principal of Expert's Firm a firm engaged in business development, technology licensing, and product development, serving the pharmaceutical, biotech and medical device industries. His qualifications include ... See full profile

New Jersey (NJ), USA

Expert in Food Product Formulation
Expert has co-developed and used fat mimetics in a wide variety of food products, specifically dairy, snack, and bakery products. He also has experience with foods such as frozen deserts, convenience foods, prepared foods, salad ... See full profile

Massachusetts (MA), 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 to the healthcare ... See full profile

Illinois (IL), USA

Expert in Biomedical Engineering; Medical Devices
Ip Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3) Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, ... See full profile

Illinois (IL), USA

Expert in Healthcare Information Technology, Biomedical Device Integration, Clinical Informatics
Expert has more than 28 years experience in mathematical analysis, mathematical analysis techniques and in the use of mathematical analysis for signal processing, simulation techniques and has experience over that time span in developing both simulations ... See full profile

Maryland (MD), USA

Expert in Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products
Expert's major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and ... See full profile

New York (NY), USA

Expert in Market Access and Riembursement of Orphan Drugs in Europe
Expert is a senior executive with expertise in International Market Access and Reibursement in Europe, UK, Canada and Australia. Expert has over 20 years experience in the pharmaceutical sector and played various roles within major Pharma/Biotech ... See full profile

Switzerland

Expert in Maintenance Planning and Scheduling, Reliability and Maintenance Management, and Plant Turnarounds
Expert is a chemical engineer with 32 years' experience in asset management consulting, training and plant operations in oil and gas, mining, chemicals, pharmaceuticals and flexible packaging in global companies. He has worked as a senior consultant with ... See full profile

Goa, India

Expert in Medical Device Technology, Clinical Research & Business Development
Expert has decades experience in Multi-modality medical imaging: digital x-ray, ultrasound, IVUS, MRI, intra-operative MRI, multi-slice and cone beam computed tomography, hybrid PET/CT and SPECT/CT, optical coherence tomography (OCT), endo-confocal ... See full profile

France

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