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Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects,…
Video Conferencing Market, Telepresence Video, Desktop Video, Unified Collaboration Systems, and Audio
Expert is a seasoned technology veteran of 26 years with 13 years' executive management experience. As Founder of his technology firm, he has been providing Technology Due Diligence, Strategic Development, Technology Transfer and Interim Management to small and medium size…
Turnarounds and Restructuring Distressed Businesses
Advise financially and operationally distressed businesses in areas of cost analysis, interim management and financial modeling. Expert in financial restructuring. Can quickly assess nearly any situation and determine a course of action, usually within a few hours. Interim CEO, CFO…
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…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Emergency Medical Services, Dispatch, Emergency Preparedness, Disaster Response
LP, EMSI, CHS-III Expert has 34 years of experience providing services, management consulting and education and training in public safety and emergency management. He has received extensive education in Emergency Services and Public Policy (fire, police and emergency medical services)…
Waterway Project Planning & Engineering Design, EIS’s, Permitting, Contaminated Sediment Remediation
Land-Forming and Waterway Engineering Project Development The processes associated with stepping through the “Project Continuum” associated with today’s high complexity/high diversity land-forming and waterway engineering projects are overwhelming. To progress through the gauntlet, each project must comprehensively address a spectrum…
Radiology Management: Operations, Generational Team Building
Expert has extensive knowledge in all radiology and imaging procedures and operations. He has directed and provided strategic oversight for hospital and outpatient ventures, and has direct working knowledge of all imaging modalities, including angiography, fluoroscopy, CT, computed and direct…
Public Safety, Occupational Health and Safety, Industrial Training and Course Development
A Workplace Accident and Injury Reduction Program, Expert has worked in the field of Accident Investigation for many years giving him the opportunity to research and establish sound reduction programs for various businesses. Expert has the ability to observe and…
Retail Security Products – Sales/Marketing, ROI Analyses, Litigation Support
Expert is an experienced expert witness for the plaintiffs in two separate federal cases involving retail security products. In addition to having broad knowledge of most electronic and mechanical retail security products, he has been awarded a patent for an…