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FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…
Medical Device Product Management, Product Launch, Marketing, Sales, and Sales Operations
Expert has over 30 years commercial experience in medical and diagnostic device product management and development, marketing, sales, operations, distribution and finance as an individual Contributor, Director, Vice President and CEO. Expert provides strategic advice to start-up medical device companies,…
cGMP Coatings, Pharmaceutical, Dietary Supplements, Adhesives, Die Cutting, Security Holograms, Printing, Operations Lean Management Metrics and Strategy, and Materials
Expert has worked in custom manufacturing – polymerization, mixing, coating and converting of cGMP adhesive and laminates - as a process engineering manager. In this role he lead operations and engineering on the corporate Business Strategy Team (BST) asserting direction…
orthopedic R&D, regulated (GLP) nonclinical trials, large animal models, surgery, vet med
Expert is the Director of the Comparative Orthopaedic Research Laboratory in the Department of Clinical Studies at the University Of Pennsylvania School Of Veterinary Medicine. Expert trained in both human and veterinary medicine, and completed an internship, residency and lectureship…
Life Sciences, Lab IT Support & Validation
Worked as a group leader as well as R & D Sr.. scientist. Expertise in analytical method development and testing. Worked with NDA and ANDA products with different clients. Directly communicating with clients regarding progress and any problems in development…
Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. Some of…
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 manufacturing industries, he works with about 30 worldwide…