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Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects,…
Regulatory Affairs for Cosmetics, Fragrance, Health Products, Good Manufacturing Practices
Expert has been nominated in 2009 as a National Court Expert in Paris (Chemicals – Cosmetics – Perfumes and Cosmetic Good Manufacturing Practices) He became licensed as well in 2009 on toxicological and safety evaluation for cosmetic products (Faculty of…
Psychopharmacology in Historical Perspective, Regulatory Behavior, etc.
Over the past 20 years he has done extensive research on the history of drug discovery, drug development, drug registration, and the use of psychopharmaceuticals in medical practice. Among the documents he has collected are the virtually complete set of…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Nanotechnology Regulatory, Environmental, Health, and Safety Issues
Expert has applied his chemical engineering education to the field of nanotechnology by providing regulatory compliance assistance to companies manufacturing and using nanoscale materials. His knowledge and experience with Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide and Rodenticide…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Clinical Pharmacology, Toxicology, Drug Development, Product Liability, Regulatory Affairs, Pharmaceutical Patents
Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimal analgesic and addiction potential. In particular, he led the research team that discovered and developed nufenoxole, an antidiarrheal drug.…
Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
Toxicology, Environmental Health and Safety, OSHA Regulatory, Mold, Healthcare and Laboratory Safety
Expert's experience is very broad in the areas of chemicals effects on humans and environmental systems. He has performed academic research on the effects of hazardous chemicals on the lungs, as well as carcinogenic effects of chemicals and air pollutants,…