|
Product Approval Experts| The following experts are available as product approval consultants and product approval expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Product Approval -
The act of approving a product to be sold, leased, or used as defined by a private or governmental regulatory agency with the assurance that the product complies with published standards which may be written by the agency. |
|
|
| 1 to 25
(of 69) | | | | Request Free
Expert Quote | | |  | | 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 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 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 Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS ... See full profile | | California (CA), 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 Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument ... See full profile | | Massachusetts (MA), USA | | | |  | | Expert in Pharmaceutical Development, strategy planning and execution
Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher Institute (FMI; ... See full profile | | Switzerland | | | |  | | 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 Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. See full profile | | Illinois (IL), USA | | | |  | | Expert in Regulatory Affairs for Cosmetics, Fragrance, Health Products, Good Manufacturing Practices
Expert has been nominated in 2009 as a National Court Expert in Paris (Chemicals – Cosmetics – Perfumes and Cosmetic Good Manufacturing Practices) He became licensed as well in 2009 on toxicological and safety evaluation for cosmetic products ... See full profile | | France | | | |  | | 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 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 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 Pharmaceutical Drug Development, Strategic Executive Management, Biopharma Mergers and Acquisitions
Expert has over 20 years of experience. He is extensively active and has significant experience and expertise in Europe and the US in the areas of drug development and financing throughout Europe and the US. He was responsible for the overall ... See full profile | | Netherlands | | | |  | | 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 Gene Expression, Genomics, Microarrays, DNA, Drug Discovery, Product Development
Expert has worked in the biotechnology industry for more than 24 years. He has directed R&D efforts in gene expression technology, genetic engineering technology, DNA microarrays, and high-throughput screening at Sandoz (Novartis), Operon, ... See full profile | | California (CA), USA | | | |  | | Expert in OTC, Generic, and New Drugs, Medical Device Regulations
Expert now consults clients on matters pertaining to OTC drugs, generic drugs, new drugs and devices regulations and performs inspections of manufacturing facilities for compliance with current Good Manufacturing Practice Regulations. See full profile | | Virginia (VA), USA | | | |  | | Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile | | Oklahoma (OK), USA | | | |  | | Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, etc.)
Expert is a consultant to the pharmaceutical and allied industries. His background includes 28 years with DuPont and DuPont Merck in a variety of positions. In his last assignment at DuPont Merck, he was Senior Director of Technology and Engineering in ... See full profile | | New Mexico (NM), USA | | | |  | | Expert in Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. See full profile | | California (CA), 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 | | New Jersey (NJ), USA | | | |  | | Expert in Biometrics, Nanotechnology, Early Stage Technology Commercialization, Information Technology
Expert founded one of the earliest biometric identification companies focusing on live-scan technology development. The company later interfaced with every major AFIS vendor. Expert has 10 patents on core biometric technologies. He has developed designs for ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. See full profile | | California (CA), USA | | | |  | | Expert in Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials
Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of pharmaceuticals. Trained in medicinal chemistry, Expert undertook clinical pharmacology research in a ... See full profile | | Victoria, Australia | | | |  | | Expert in E-beam Imaging Product and Material Development, Laser, FDA Radiation and Product Safety Compliance
Expert is a well-qualified professional with more than 15 years of experience in designing electronic products and materials for high kV electron beam and x-ray imaging applications . He has got extensive knowledge in image processing and ... See full profile | | California (CA), USA | | |  | | >> Next 25 Experts
|
|
| |
|
