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Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
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…
Wastewater Plant Design, Wastewater Plant Operation, Terrorism Prevention Engineering
He has over thirty years of experience as Environmental Manager, Engineer, Professor, Auditor, American Borate, Expert Witness, etc. Has ample expertise in the following: Civil and Environmental Engineering, Construction Inspection & Management, Business Development, Risk Assessment, Policy, Planning, Lobbying, Industrial…
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…
Electromagnetic Compatibility (EMC): Design Analysis, Testing/Troubleshooting
Expert's competency lies in all aspects of product design related to electromagnetic compatibility with nearly 40 years of applied EMC engineering design. This includes both conducted fields and radiated emissions plus immunity requirements for North America, Europe, and worldwide regulatory…
Government Relations, Emerging Market Political Risk, Industry Analysis – Oil, Gas, and Mining
Expert, who holds a doctorate in Political Science from MIT, is a political risk specialist. She is a founder and principal of Employer, where she advises clients on political risk and mitigation strategies. In particular, Expert has expertise in emerging…
Substance Use Disorders, Healthcare, Call Center Operations, Compliance, Quality Improvement, Strategic Planning, Mail Order, and Healthcare
C-SUITE EXECUTIVE Expert is a results-oriented, tested “C” class executive with extensive experience at driving the strategic direction and enhancing the operational functioning of organizations. Reputation for serving as the executive point of contact for all stakeholders, recommending data-driven change…
Chemical Analysis and Quality Assurance
She has expertise on Varian instruments ICP-AES; ICP-OES; AAS; GC-MS; NMR; Pelkin elmer ICP-OES; FT-IR; Schimatdzu HPLC; Elementar CHNSO; LC-MS; JEOL EPR; Bruker NMR operation and interpretation of results of various metal containing complexes and compounds of organic nature such…
Legal, Business and Technology Issues, Disaster Planning & Risk Management
He has been involved as an executive in business of all sizes ($2,000,000 to $100,000,000). He appears regularly on a business radio show (540 WFLA) which helps people buy, sell and run their businesses. He has been a primary person…
Transportation: USDOT-USEPA-NHTSA-CARB, Safety Policy, Environment & Energy Programs, Gov’t Relation
Expert is totally knowledgeable in all the fields of automotive systems safety( passive and active ). He has advised Volvo( the leader) of trends in the market place as well as the governmental trends in the US and Canada. He…