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Nanotechnology, Biomaterials, Sol-gel Sciences, Optics, Biotechnology, Glass, Ceramics, Spectroscopy
Expert is a specialist of sol-gel chemistry. He developed a new non-aqueous method for sol-gel glass coating to obtain transparent films for integrated optics and photonics using polysiloxane materials. The aim was to obtain low-softening temperature glasses to permit facile…
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…
Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
Healthcare IT Sales, Hospital Quality and Risk Management Software, and Healthcare Reform Software
Expert's specific experience with implantable devices comes from selling Orthopedic implants, in particular, total joints like hips and knees, and trauma devices in the Operating Room. Other products include Osteobiologics like pig skin for soft tissue repair. He facilitated over…
Protection Design, Testing, Data Analyses, EMP, EMC, COMSEC, ZONING, TEMPEST
The electromagnetic protection process is an evaluation of risk assessment against criteria (EMP, EMI/EMC, TEMPEST, EM-health). The entire process covers mainly: risk evaluation, design, construction, maintenance and testing. Starting from the risk evaluation, the different aspects of electromagnetic protection can…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…
Microbiology, Biotechnology, Cleanroom Microbiology, Sterilization, etc.
As a consultant, Expert has used his broad-based scientific background to work with a variety of clients. These clients have required expertise in such widely divergent subjects as the production of cellulosic ethanol (requiring a knowledge of basic thermodynamics, enzyme…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…