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New business development & new product applications for domestic & International businesses
Expert is founder and president of an international marketing group. Prior to forming his company, he was a principal of a LLC, Vice President, Sales and Marketing as well as many other executive roles in his career. He has over…
Polymer Science, Adhesives, Adhesion, Biomaterials, Medical Device, Analytical Chemistry
Experienced Research And Development Scientist with an innovative collaboration mindset enabling over 85 patents/applications in the medical device industry. Strong research professional skilled in Medical Devices, Biocompatibility, Regulatory Support (EU-MDR), Surface Science, Nanotechnology, Coatings, Adhesion and Adhesives, Polymer Chemistry, Biomedical…
Business Optimization, Engineering, Analytical Rigor, Technical Expertise, Due Diligence, Critical Business Analysis to Develop/Implement Change for Profitable Growth
We fuse business optimization, engineering expertise, analytical rigor, and technical expertise to help companies perform due diligence, critical business analysis and design/implement continuous improvement programs to achieve profitable growth. Our firm provides expertise in commercial development, new product development, sourcing,…
Pharmaceutical, Drug, Medical Device, and Management
Expert is a Pharmacist and an Attorney with a MBA and has worked in the pharmaceutical/biotech/medical device industry for 25 years.
Plasma Physics and Pulsed Power
Expert has a Ph.D and over 10 years' experience in the analysis, design, commissioning and operation of large power and control systems associated with plasma physics experiments. His experience includes DC and pulsed power systems, high-voltage and high-current systems, and…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…
Medical Devices
Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards. Overview of Skills:…
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…