Accomplished Senior Pharmaceutical Executive, Consultant and Entrepreneur with a documented record of success in corporate and operations management, cGMP and regulatory compliance, Quality Management Systems, Product Development and strategic operations/business development.• Founder and CEO of 2 companies in contract Pharmaceutical Services & Information (clinical) Technology with full P&L, corporate and market development, C-level sales, licensing and M&A responsibility. Extensive experience in Quality Control and Quality Assurance. Extensive experience Formulation Development including Rx (parenterals, solid and liquid dosages), OTCs and Medical Devices. Extensive experience in Process and Product Development including Rx (parenterals, solid & liquid dosages), OTCs and Medical Devices.• Business Development & Operations Improvement Consultant in Pharma and Homeland Defense.• Senior Corporate Quality Assurance & Technical Services Executive for four (5) Pharma and one (1) start-up Biotech Company.• Product and Business/Market Development for a Clinical Information Technology Company. • Directly responsible for building/re-engineering 6 Quality/Technical Services programs and a Regulatory Affairs and Clinical Operations programs. • Pharmaceutical Product and Technology Planning, Development and extensive Project Management Experience.• Extensive background in Pharmaceutical Operations (Regulatory Affairs, Clinical Materials, Quality and Tech Services); Organizational/Systems/Services Development; Scientific Affairs (NDA, BLA, ANDA, CMC section submissions); Strategic Planning; Facility/Process & Computer Validation.Specialties: New Product Pharmaceutical Development; Cross-functional Team LeadershipQuality Management; Technical Services and Validation: Regulatory Affairs; Risk AnalysisKnowledgeable and experienced in Homeland Defense and Soldier Protective technologies