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Formulation Development
Expert has over 20 years of versatile, industrial experience in areas of the pharmaceutical preformulation, formulation and process development and technology transfer of all oral dosage forms and parenterals dosage forms with leading companies as TTK, Parke-Davis, Strides, Banner Pharma…
Medical Device Strategy, Up-stream Marketing and Commercialization
Expert has over 30 years marketing experience in the healthcare industry. During his career he has launched over 20 products in the USA and internationally. Products launched include electronic medical equipment, durable medical equipment, medical plastic consumables, and medical software.…
Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…
Water Quality, Water Conservation/Management, Ecosystem Management and Sustainable Agriculture
Innovative treatment systems and technologies for water pollution prevention and management have been the core of Expert's professional carrier for the past 20 years. Focusing especially on sustainable design, functionality and cost-efficiency, over the past several years she has worked…
Title Insurance, Standard Claims Practices, Interpretation of legal documentation
Attorney and Consultant / Expert Witness on title insurance management, escrow and related matters From an industry experience perspective, Expert has been actively involved in all phases of the title insurance industry from the period where he was issuing title…
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…
Clinical Development, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…
GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
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…