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Oil, Gas and Power; Development, Regulatory and Commercial Matters
Expert has extensive experience in international energy sector commercial matters, in opportunity identification, business development and project realisation. This expertise spans all levels of government and private sector relationships from direct negotiations with the Presidents of national states to forming…
Environmental Services, Regulatory Compliance, Waste Transportation & Disposal, Landfills
20+ Years Environmental Management Experience / Leader in Business Strategy & Acquisition / Western US Facilities Oversight / Training & Regulatory Compliance / Human Resource Management & Professional Growth Expert is a results-driven business professional with 20+ years’ experience in…
Drug Discovery & Development, Preclinical Safety Assessment: Toxicology, Pathology & Regulatory affairs
ExpertS. Expert has over 33 years of experience in safety evaluation- Toxicology & Pathology – histopathology slides evaluation, Regulatory, drug discovery & development research, having worked in Switzerland, UK, Sweden and India. He has experience both in the pharmaceutical Industry…
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,…
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,…
Software – Quality Assurance, Regulatory Affairs and Licensing
Expert has over 25 years experience of delivering software solutions/applications to healthcare industries, including R&D, Manufacture and point-of-care delivery (e.g. hospitals). This includes negotiating the difficult areas of licensing in Europe, the USA and beyond, accreditation and certification to ISO…
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…
Financial Technology, Market Surveillance, Regulatory Systems
He is currently an expert witness in a case involving high-frequency trading and the improper handling of orders on the leading option exchanges. The case requires expertise in market surveillance and regulatory technology associated with order audit trails, alerts and…
Chemical and Regulatory Environmental Health and Safety Compliance Services
Expert has over 25 years' experience in regulatory environmental compliance consulting and servives in the following areas: 1) Plans and permits for obtaining air quality, industrial waste, storm water, treatment, and underground storage tank (UST) permits for chemical plants and…
Drug Regulatory Affairs (European Union)
Expert has nearly 20 years experience in Drug Regulatory Affairs (RA). Before setting up his own RA consultancy in June 2008, he has worked in various senior RA positions in the pharma and biotech industrie having been located in Germany,…