Consultant in Drug Discovery and Development; Preclinical and Clinical Drug Metabolism and Pharmacokinetics, Toxicokinetics, and Clinical Pharmacology; Preparation and Submission of IND's/ERC's and NDA's/MAA's.Over 35 years of experience in the discovery and development of novel drugs in multiple therapeutic areas (anti-bacterial, anti-inflammatory, anti-viral, cardiovascular, central nervous system, oncology, ophthalmic, pulmonary, and renal).Strong managerial and leadership skills with scientific expertise in the areas of drug discovery and development, preclinical and clinical drug metabolism, pharmacokinetics, and clinical pharmacology...

Ph.D Pharmaceutical Regulatory and Laboratory Compliance, Quality Assurance and Controls (cGMP, FDA, ICH, EMA, ISO) ConsultantPharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).Laboratory quality systems for both pharmaceutical development and quality control testing.Complete laboratory outfitting including qualification and method implementation.Test method development, transfer and validation.Analytical measurement and techniques.Auditing systems and processes.Analysis of APIs, raw mate...

Pharmacokinetics Consultant Specializing in Drug Metabolism, Drug Discovery and Early Drug Development.ADME, (Absorption, Distribution, Metabolism, and Excretion) and PK (Pharmacokinetics) in drug discovery.Early drug development.In vivo and in vitro enzyme induction.Cytochrome P450 enzyme inhibition and potential for drug-drug interaction.In vitro and in vivo metabolism and metabolite profiling.Preclinical studies to evaluate ADME, toxicokinetics, and PK profile of drug candidates.Due diligence to evaluate DMPK profile of drug candidates for potential purchasing or in-licensing opportunities.Interaction with CROs for contracting and monit...

Pharmaceutical Analytical Chemistry Consultant Specializing in Method Development, Method Validation, Cleaning Validation and Verification, Drug Stability and cGMP, FDA and ICH Quality and Compliance.Analytical method development and method validation for small molecule pharmaceuticals.Cleaning validations and cleaning verifications.OOS (Out of Specification) and OOT (Out of Trend) investigations.Stability management.Setting specifications for finished products and API.Project management for CROs (Contract Research Organizations).Formulation development support.Pharmaceutical quality control.Protocol and SOP (Standard Operating Procedures...

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Expert and Consultant for Pulmonary Toxicity and Related Lung DiseasePulmonary fibrosis and pulmonary pathology.Lung diseases such as asthma and bronchitis.Environmental lung disease.Metal toxicity, vanadium toxicity.Carbon nanotube pulmonary toxicity.Occupational lung disease.Air pollution particles and associated lung disease.Research InterestsCellular and molecular mechanisms of pulmonary fibrosis and chronic airway remodeling in asthma and bronchitis.Disruption of intracellular signaling pathways by air pollution particulate matter and metal-induced oxidative stress, particularly vanadium pentoxide.Pulmonary responses to manufactured c...

Toxicologist Consultant and Expert Witness with Worldwide ExperiencePracticing toxicologist of over 20 years providing testimony to governmental agencies, service as an industrial site crisis team member, media (BBC) consultant and services as an expert witness in the United States, United Kingdom and Hong Kong in the following areas: Chemicals Accidents: Chemical and chemical exposures Pesticides and biocides Toxicology Risk Assessment: Drug toxicology and drug testing Building fires and resulting combustion products Chemical fires and explosions Plastics fires and plastic combustion by products Effects/Reactions: Drug...

Pharmaceutical Chemistry Consultant for Drug Discovery, ADME, and Drug Toxicity and Drug SafetyPharmaceutical drug discovery process and implementation.Drug discovery and medicinal chemistry.Preclinical pharmacology, ADME (absorption, distribution, metabolism, and excretion of drugs) and pharmaceutical toxicology and safety.Pharmaceutical drugs for anti-infectives, anti-virals, oncology and immunology.Pharmaceutical drugs for cardiovascular and metabolic disease.Pharmaceutical drugs for diabetes, obesity, aging and frailty.Due diligence assessments, including intellectual property.

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

Medical Doctor focused on cures for short term memory lossCentral cholinergic mechanisms (nucleocortical and septohippocampal pathways) related to the learning process and short-term memory in normal and aged brains.Experimental models and tests of acetylcholine as a neurotransmitter in learning and memory loss.Screening of compounds (such as pyroglutamic acid, oxiracetam, aniracetam and pramiracetam) with the potential of use in humans for Alzheimer's disease and other age-associated memory impairments.Expertise in European pharmaceutical research and development and common technical documents.Managing and monitoring Phase 1 and 2 clinica...