Find an Expert
Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
Adhesives, Coatings, Materials and Process Chemistry
Expert is a professional chemist with 35+ years experience in academics, commercial, aerospace, electronics, and automotive-related industries. A hands-on consultant on various aspects of engineering materials, their applications and processing, with extensive experience in materials and process engineering, product research…
Motion Sensors, Occupancy Sensors, Passive Infrared, Analog, Digital, Electronics & Proposals
Degreed, self-starting Electrical Engineer (BEE) who specializes in digital and analog circuit and system design and hardware, firmware, and software development. Skilled in the design, invention, and innovation of high technology security electronics. Extensive background in digital circuitry enhanced with…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…
Hazardous Locations Equipment Certifications (Intrinsically Safe), Gas Detection
Expert has 16 years of experience in designing, assessing and certifying equipment to national and international standards for intrinsically safe equipment. He has designed many intrinsically safe devices, including gas detectors, fire detectors and other systems. Applied standards include UL…
Flexible Packaging Materials; Film Extrusion, Extrusion Lamination, Food Packaging, and Food Packaging Safety
Fellow, Society of Plastics Engineers Inductee, Packaging Hall of Fame Expert has spent over 35 years in the development and application of functional materials for a variety of packaging and non-packaging applications (process and platforms). He has developed various multi-layered…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
International Industry Specialist in World Class Manufacturing
Expert consults internationally. He has designed and reengineered manufacturing plants for world leaders in their respective fields of manufacturing. Expert's work in the area of performance improvements has been exceptional with achievements of 770% and higher for his clients. Expert…