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Expert in 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…
Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Expert in General Anesthesia, Cardiac Anesthesia, Pain Management,Implementation of Electronic Medical Records
Expert is Director of Anesthesiology, Medical Director, and an Expert Medical Review Consultant for the State of California Medical Board. His medical practice includes all aspects of anesthesia including an active interventional pain management program and a cardiothoracic practice. Currently,…
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…
Expert in Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
Expert in 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…
Expert in Product Development, Mechatronics, Mechanical Engineering, Electromechanical Engineering, Analytical Instrumentation, Machine Design
Expert is an Independent Consultant who advises clients about the Engineering, Design, and Development of complex systems and products. His philosophy is to help clients find the best path for their unique situation. In addition, he is an expert at…
Expert in Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Expert in Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Technological / Scientific Infrastructures Speed to Markets • Advising and Strategically Coordinating with the Following Agencies: World Health Organization COVID-19 Accelerator Cure Project Linking Collaboration Platforms for Best in Class Teams around the world The Directorate for…
Expert in Problem Solving, Project Management & Rescuing, Automation, Security & Safety, SWE, RTD, QA, Training & Education
A PhD from Reading University (UK), Dr.Ing. and MSc in Electronic Engineering from the Politecnico di Milano, eMBA in ICT System Management (SDA-Bocconi) and Software Engineering (IBM-IFDA) plus additional qualifications in several domains spanning from Forensics to Psychology. Over 30…