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Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Scientific, Clinical, Medical, and Regulatory Affairs
Expert is a senior executive and a global biomedical leader with expertise in all facets of basic, pre-clinical, clinical research, and regulatory science for drug, biologic, therapy, vaccine, and medical device development. Expert is a leader in strategic planning and…
Value-Based Healthcare, Payment Integrity, Analytics and Informatics, and Payer-Provider Collaboration
Expert has implemented a wide variety of value-based care models at more than 600 hospitals and health plans. He is recognized as an expert in Population Health, Bundled Payments for Care Improvement (BPCI), Comprehensive Care for Joint Replacement (CJR), MACRA,…
Radiation Oncology, Head and Neck Cancer, Breast Cancer, Lung Cancer, Prostate Cancer
Expert. Expert is a board certified radiation oncologist. He obtained a BSc and Master's degree in Biomedical Engineering from McGill University, then went on to attend medical school and residency training in radiation oncology at McGill University Health Center. He…
Design for Manufacturability, Mass Customization, Build-to-Order, Concurrent Engineering
Expert is a const reduction expert that helps companies reduce cost as much as half the total cost through product development and cost savings through on-demand production and spontaneous (pull based) supply chains. He has developed leading-edge methodologies that show…