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Pharmaceuticals & Healthcare in Brazil: Entry Strategy, Market Evaluation & BD
Expert has ran 6 pharma & healthcare businesses as General Manager/CEO/President in his 40 years in Brazil ranging from subsidiaries of US, German, UK & Latin American labs to local start ups. Businesses covered Rx & hospital products, OTCs &…
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…
Bulk Solids and Material Handling, Plant Design, Site Master-Planning and Project Management
Expert holds two patents for Powder Handling System; he invented a new instrument for measuring solids flow rate using a vision system with great accuracy. Expert draws upon 22 years of solid experience in powder and bulk solids handling where…
Systems and Processes in Clinical & Regulatory in Pharmaceutical, Healthcare and Health Insurance
Accounting ethics | Expert is a CPA, member of AICPA and NYSSCPA. Expert has global experience with pharmaceuticals, focused on corporate integrity agreements and Physician Payment Sunshine Act, interacting with finance, audit, clinical and regulatory teams, physicians and non-physician investigators,…
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…
Printing, Premedia, CrossMedia, Inkjet, Publishing, Expert Witness Services
Expert L. Expert is the principal consultant of his company, a firm specializing in process analysis, and strategic development of firms in the fields of electronic publishing, design, premedia, and printing across the globe. He began in the graphic arts…
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…
Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert. Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of cardiac rhythm devices.…
Medical and Semi-Conductor Machinery Design and Manufacturing – Solidworks Modeling
Expert has designed precision machinery for 25 years. Much of this was for semi-conductor companies at which time he gained extensive experience is high speed applications requiring the use of piezo-electrics, air bearings, FEA modal analysis. He received a patent…
Clinical Epidemiology, Public Health Medicine, Drug Safety, Clinical Trials
Expert is Director of Pharmacoepidemiology in a Public Health Consultancy providing advice and expertise to the public, regulators and medical professionals on the evaluation and safety monitoring of drugs in the European Community. He has: conducted state-of-the-art pharmacoepidemiological studies including…