Find an Expert

Expert ID: 729752 New Jersey, USA

Expert in Medical Device Design Control and Software Validation

Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…

Expert ID: 729658 Georgia, USA

Expert in Flexible Packaging Materials; Film Extrusion, Extrusion Lamination, Food Packaging, and Food Packaging Safety

Expert has spent over 35 years in the development and application of functional materials for a variety of packaging and non-packaging applications (process and platforms). He has developed various multi-layered barrier films for direct use and for use in laminations.…

Expert ID: 729566 Illinois, 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…

Expert ID: 729311 New Jersey, USA

Expert in FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media

Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. He serves on multiple brand advertising and promotional…

Expert ID: 728922 Ohio, USA

Expert in Biotechnology, Pharmaceutical, Diagnostic and Medical Device Development and Licensing

Expert. Expert has been involved with biotech and pharmaceutical drug development for over 12 years. She has worked as protocol physician or development team leader in inflammatory bowel disease, osteoporosis, sexual dysfunction and gout. She has led the development of…

Expert ID: 728254 California, USA

Expert in Rapid Development of Controlled Release Drug and Drug-Device Combination Products

Expert, Ph.D., is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, with special focus on drug delivery platforms and drug-device…

Expert ID: 727211 California, USA

Expert in Biodegradable Systems for Controlled-Release Drug Delivery

Expert has a D.Sc. in bioorganic chemistry, a Ph.D. in polymer chemistry and over 25 years of experience in analytical and physical chemistry of biopolymers. In a very recent assignment Expert has established and directed an analytical chemistry department with…

Expert ID: 726016 New Jersey, 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…

Expert ID: 725868 Montana, 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 advertisements.…

Expert ID: 725075 Minnesota, 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). These products are generating over $100 million dollars in…

Dev Tool:

Request: experts/food-and-drug-administration-regulation/page/2
Matched Rewrite Rule: ^experts\/([^\/]*)\/?([^\/]*)\/?page\/([0-9]{1,})\/?
Matched Rewrite Query: pagename=experts&searchKeyword=food-and-drug-administration-regulation&searchDiscipline=&paged=2
Loaded Template: page-experts.php