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Neuroscience, Auto-Immune Drug Development, and the CDMO Sector
Expert in Neurology at the clinical stage and rare disease specialist with deep domain knowledge and financial acumen. He is an entrepreneurial builder of brand intelligence, growing contract manufacturing consultancy to high profile industry recognition and B2B sale at full…
Material Science and Metallurgy
FAILURE ANALYSIS Expert's failure investigations have encompassed a wide range of oilfield products including, but not limited to, wellhead and Christmas tree equipment, rock bits, OCTG, motors, packers, and downhole tools. Failure investigations have included but not been limited to…
Green and Clean Energy: Petrochemical, Refining, and Downstream Chemical and Utilities Sectors: Pre-commissioning, Commissioning, and Plant Startup
Executive summary: Expert has 17 years' experience in the petrochemical, refining, and downstream chemical and utilities sector. His experience includes pre-commissioning, commissioning, plant routine startup, shutdown, and emergency operations. His management roles include service as process trainer and process commissioning…
Metallurgical and Failure Investigations Caused by Corrosion, Degradation, Biological Activity, Fatigue, and Overload in Metallic/Non-Metallic Materials
After gaining a Ph.D. in Solid State Physics, Expert spent three years tertiary teaching, eight years of university research on materials and materials degradation, and, since 1985, consulting for industry on failure analysis, corrosion mitigation, and materials selection. Since 2001,…
Formulation Science, Formulation Chemistry
Expert is an experienced ‘Formulation Scientist’ offering outstanding Product Development skills for Oral Liquids, OTC Products, Hand Sanitizers, Personal Care Products, Topicals Products, Tablets, Parenteral Products. Expert can also help in modifying existing formula, offer expert guidance on product design,…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
PE, RPLS, CFM – Civil Engineer, Utilities and Drainage
Civil engineering, water and wastewater utilities, drainage and flood control. Forty years of experience in civil and environmental engineering and project management. Designed and managed construction for more than $900M of public works, private and federal projects, including heading design…
Digital Transformation: Risk and Engineering
Working with global and international clients and organizations to address emerging, evolving and rapidly changing enterprise risk, governance, risk and compliance, operational risk and resilience, business continuity, crisis management, organizational and digital transformation, as well as control system testing, review,…
Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…