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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…
CDR and Reconstruction, Defective Industrial Equipment/Processes, Product Development, Manufacturability and Launch
Expert has been performing insurance and forensic loss type Contractor work since 1996. Starting as a sole proprietorship with automotive warranties, but was capitalized on by a forensic engineering company for inherent knowledge and experience of industrial process and product…
Assembly Tooling, Wire Drawing, Cable Insulation, Safety Label Inspection, Noise & Pollution Control
He has extruded Polypropylene, PVC, Polyethylene and Swiss had to design screw for each. He designed tools for extrusion. He has extruded, Thermoplastics and Hypalon and rubber and design screws for each. He designed tools for extrusion. He has designed…
Computer Science: Embedded-Computer Systems, Statistical Analysis, Data Recovery, Languages
He carries out forensic consulting, writes specialized computer programs both for others and for his own amusement, edits technical books, tutors in English for speakers of other languages, serves as treasurer for not only the local Emergency Squad but also…
Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in…
Surface Treatment, Shot Peening & Blasting, Zinc Plating, Phosphating, Carburizing, Heat Treatments
Expert has very good expertise on Blast cleaning and shot peening. He has proved his expertise in many industries, and shown phenomenal savings on blasting agent cost, good quality of cleaning and good environment. Expert helped in identifying the issues…
Foundry, Investment, Permanent Mold, Squeeze, Low Pressure, Casting, Ferrous, Non-ferrous Alloys
FOUNDRY & CASTING TECHNOLOGY: Expert (Foundry Project Consultant & Metal Casting Consultant) has worked with various molding, casting processes: expertise in process, materials sourcing; product costing; pattern, die design, conversion of weldment to casting, electroslag refining, continuous & direct chill…
Mechanical and Materials Engineering: Fractures, Failures, Explosions, Pressure Vessels and Systems
Expert has worked in ASME, API, EN, BS, AS and other international design codes especially in pressure equipment in the nuclear, fossil fuel, petro-chemical, transportable and gas cylinder industries. He has worked on code development in both Europe and Australia.…
Materials Science, Particularly Corrosion: Microbial Corrosion, Materials Selection, Biodegradation
Biodegradation mainly refers to enhanced degradation and deterioration of non-metallic materials such as concrete and polymers to distinguish it from microbial corrosion of metals. Under certain circumstances, there are groups of micro-organisms that are capable of attacking these materials and…
Packaging Design, Ethnographic Research, User Study, Industrial Design, Plastic Part Design
Expert has been practicing concurrent engineering for the last five years and this business strategy has brought him to consider all the tasks in parallel during initial design stages. Since Expert has designed products meant for mass market, this strategy…