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Strategic Management Consulting and Market Research
Expert is the founder of a strategic management consulting firm serving the pharmaceutical, biotechnology, medical diagnostics, genomics, proteomics and contract research organization industries. Her clients include major pharmaceutical companies, biotechnology companies, invitro diagnostics firms, genomics companies, venture capital firms, CROs…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…
Virology, Drug Discovery, Diagnostics, Bioterrorism, and Vaccines
Expert (, pronounced "Berr-oo-in") has spent over 20 years in the pharmaceutical and diagnostics industries. During that time he has been involved primarily in viral vaccine and antiviral drug discovery, although he has also run general molecular biology groups primarily…
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…
Clinical Applications, Microbiology, Biotechnology, Diagnostics, Immunology, and Custom Speaking
Expert has been involved in the identification of biological molecules associated with disease and infection with bacterial and viral agents. By applying molecular techniques to vaccine and infection models, he has identified immunological (antigenic) markers of bacterial infections of human…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
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,…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Molecular Biology, Molecular Pathology, Polymerase Chain Reaction Technology
Expert has expertise in the adaptation and development of molecular biological techniques to answer medical questions of human genetics, differential gene expression, diagnostics, epidemiology, and pathogenesis, particularly in regard to infectious agents and genetic diseases. The CGS is a multidisciplinary…