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International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…
Product Development, Quality Assurance, GMP Audits, Qualifications, Troubleshooting, Pharmaceutical, Nutraceutical, Production Issues, GMP Compliance, Pharmaceutical Dosage Forms, Quality Control
Expert has more than 24 years of experience Internationally (New Zealand; Australia; Oman, and India) in pharmaceutical formulation plants, Product Development; Analytical development; Scale-up, Technology transfer; Manufacturing, Quality Assurance; quality control (testing and releasing); Lead regulatory audits and meet the…
Retail Products, Luxury Goods, Corporate Communications, Valuation, Finance, Start Ups, E-commerce
Expert has focused on valuation, including all of its methods and the sub-sections that are under debate, for several years and has worked on in-depth projects regarding solvency, financial service firms, and intangible goods. She also has experience with financial…
Paper Industry, Paper-based Packaging Industry
Expert has helped numerous clients identify and develop new busienss opportunities through his strategic focus on growth consulting Expert has completed numerous competitve analysis across many industry segments for clients interested in assessing the market or competition in a particular…
Personal Care Cosmetics, Skin & Underam Care-Formulation Development-Application-Claim Support, INC Regulations, Ingredients, Formulation, Expert Witness
Besides working as Senior Principle Scientist for Kao Brands (Curel Technical Brand Mgr, Jergens Technical Leader, Ban AP innovation, John Frieda Innovation), Expert has worked for Dow Corning as a Senior Technical Service Scientist in the field of silicone chemistry,…
Polyurethane Foam Formulations/Processes,Automotive Acoustical Parts,Fibers/Plastic Recycling
Expert has leveraged his graduate/post-graduate academic training in organic chemistry and his doctoral dissertation work with organo-metallic compounds to an in-depth knowledge of, and expertise in: -chemical intermediates -fine chemicals -fine chemical intermediates -polyurethanes He has specifically applied this theoretical…
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…
Aerial Remote Sensing, Mapping, Surveying, Photogrammetry and GIS
Expert has planned many aerial survey tasks for mapping, reconnaissance using large format aerial cameras, ALTM systems and other sensors like aeromagnetic scanners, Deadulus scanner etc. He has good track record of fixing flying altitude, scale and selecting type of…
Identity and Image (Corporate Identity and Public Image) and Motivation
MTV, Hollywood's David Foster and Brian Wilson, Taiwan Trade, 300th Anniversary of the founding of St Petersburg, Russia, RosAtom, plasma waste management, bio-remediation fertilizers and carbon fiber production in the EEU, Expert has successfully designed and redesigned organizational entities domestically…
Architectural Structural and Forensic Engineering
His degree is a Bachelors of Architectural Engineering where he learned the application of engineering principles and technology to building design and construction. His specialty is in Structural Engineering but he took advanced courses in HVAC design as well as…