Pharmaceutical Chemist and Former FDA Manager GMC, FDA Compliance and Expert WitnessRegulatoryFood and Drug Administration compliance.Prepare submissions to the Food and Drug Administration.Quality audits and implementation of changes.Simulated FDA inspection - quality and readiness audits.Establish and review quality assurance procedures for GMP and GLP.Develop and write appropriate Standard Operating Procedures (SOPs).Assist firms with Consent Decrees, Warning Letters, and 483s.Chemistry, Manufacturing, and Controls (CMC) expert.TechnicalLaboratory procedures and documentation.Pharmaceutical package and labeling and product compatibility...

Medical Doctor Consulting on Medical Imaging in the Clinic, Specializing in MRI, for Imaging Equipment, Applications and Business.Medical imaging in clinical development.MRI of the breast and abdominal MRI applications.Diagnostic imaging contrast agents.Imaging surrogate markers.Imaging core lab sourcing and management.Diagnostic imaging and medical imaging informatics.Breast cancer imaging, particularly MRI.Radiology research and overall medical imaging technology.Medical imaging devices.Medical imaging product development, marketing and sales.Hospital and clinic purchasing of imaging equipment.Radiology management services for health ins...

Hospital, Nursing Home and Health Care Safety. Medical Devices - Use, Safety & Design. Electrical and Electro Mechanical Devices. Forensic Services - Product Liability and Institutional Negligence.Hospital, nursing home and health care safety consulting.Medical Devices: Use, misuse, safety and design.Consulting related to electrical and electro mechanical devices safety and use.Forensic Services: Product Liability and Institutional Negligence.Safety Consulting Areas of Experience: Apnea Monitors, Biomedical Chiropractic Devices, Burns from Medical Treatment, Defibrillators, Dental Equipment, Electrical Wiring and Fires, Electrical/El...

Molecular biology consultant expert in pharmacology, oncology, endocrinology with expert witness and interpreter of scientific literature experience.Pharmacology: Mechanisms of drug action and side-effects.Oncology: Specializing in breast cancer, endocrine regulated cancers and lung cancer.Endocrinology: Hormone replacement therapy with estrogens and progestins.Steroid receptors, steroid hormones and mechanisms of action.Dose-response curves: Tamoxifen, raloxifene, fulvestrant, SERMs, letrozole, anastrozole, exemestane and aromatase inhibitors.Molecular biology, biochemistry, biophysics.Recombinant DNA technology, PCR, mutagenesis, cl...

Mechanical and Biomedical Engineering Consultant and Expert Witness Focused on Forensics, Accident Reconstitution, Injury Causation and Products LiabilityMechanical and biomedical engineering.Accident reconstruction: Auto, motorcycle, bicycle, pedestrian, railroad, marine and aviation.Forensic engineering.3D laser scanning.Injury causation biomechanics & personal injury.Product and premises liability.Engineering analysis/R&D/FEA.Medical devices and regulatory affairs.Patent infringement....

High voltage electrical equipment design, use, safety, training and accidental investigation for insurance and litigation.Electrical accident investigation involving high voltage equipment, electrical safety and site procedure review.Expert witness consulting for the insurance industry and litigation support for legal counsel.Technical support for legal case preparation.Expert opinion reports and document review involving electrical safety, OSHA regulations and electrical engineering practice.Electrical safety training, marketing and training video production and electrical safety and training administration.Electrical power, control equip...

Electrical Engineer Consultant for design and analysis of antennas, arrays, propagation paths and transmitter and receiver componentsElectrical engineering design and analysis of antennas, arrays and propagation paths.Electromagnetic measurements and calculations for communication and radar systems.Expert testimony concerning health effects of electromagnetic waves.Wireless communication systems, including broadcasting, ultra wideband (UWB) and cellular telephony.Examples of Specific Consulting ActivityRadio and Television Broadcasting: Engineering designs and analyses of antennas, arrays, signal propagation paths, transmitter and recei...

Medical device compliance and validation specializing in blood glucose monitoring devices.Blood glucose monitoring devices.Validation of analytical methods, validation plans for facilities and utilities.Regulatory compliance for diagnostic medical devices, bulk chemicals, liquid therapeutic dosage forms, solid dosage forms and bulk API chemicals.Sterile product processing of small and larger volume parenterals.Fermentation processes and semi-synthetic antibiotics production.Solid dosage product processing and controls.Documentation and archiving and paperless systems.Compliance with CFR 21, Parts 11, 210, 211, 620 and 810.Training in compl...

Medicinal Chemistry Consultant, Experienced Expert Witness, and Patent Agent Specializing in Drug Discovery, Drug Design, Intellectual Property Rights, Patent Application and ProsecutionTechnical ExpertiseMedicinal chemistryDrug discovery and developmentHit to lead optimizationStructure based drug designFragment based drug designMolecular modelingBiological TargetsVoltage gates ion channelsLigand gated ion channelsG protein-coupled receptorsKinasesTyrosine phosphatasesMetalloproteasesDisease StatesCardiovascular diseaseOncologyChronic pain and inflammationNeurodegenerative diseaseOsteoporosisArthritisIntellectual Property ExpertiseRegister...

Automotive Technology and Alternative Energy Mechanical Engineering Expert with Expert Witness ExperienceMechanical engineeringAutomotive technology.Alternative energy.Combustion, emissions, fluid mechanics, thermodynamics, heat transfer, power generation, air conditioning and power transmission.Patent prosecution support, development and marketing of novel concepts, development of strategies to defend against infringement litigation and development of technology workarounds to avoid infringement.Expert Witness ExperienceProduct LiabilityCase involving injury to a dental patient who was injured by an overheated dental hand piece - retained...