Pharmaceutical Microbiology Quality and Regulatory Consultant with Expertise in Process Validation, Steam Sterilization, PDA's, ASQ Certified.Regulatory affairs and quality assurance certified with ASQ.Over Twenty-five year's expertise in sterile process validation, steam sterilization and aseptic processing.Pharmaceutical microbiology, and chaired PDA's Microbiology and Environmental Monitoring Interest Group for over fifteen years.GMPs, data integrity, sterile process validation, steam sterilization, microbiology, environmental monitoring, regulatory updates, and conducting regulatory submissions.Expert Witness ExperienceInternational pa...

Experienced Senior Scientist Obtains Proven Track Record in Research and Product Development, Support, Validation. Clinical Assay Development, Medical Devices, Planning- Executing 510(k) Applications.Summary Experienced Senior Scientist with a proven track record in research and product development/ support/ validation. Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications. Subject matter expert for chemistry and test method validation on behalf of clients’ companies. Numerous processes validation during compli...

Ph.D. Pharmaceutical-Nutraceutical Formulator and Consultant for Industrial Pharma and Nutraceutical, Tablets, Capsules, Health Foods, Soft Drinks, Diary, Snacks, Nuts and Seeds, Gums in Food Products, Pectins,Nutraceutical and pharmaceutical formulation and manufacturing.Formulating hemp Cannabidiol (CBD) products.Pharmaceutical Formulation Scientist with prior industry, FDA experience in CMC writing for small molecules and biologics for both FDA and EMA.Tablet and capsule formulation, manufacturing, trade secret infringement, product labeling, and patent evaluation.Formulation and manufacturing of food, nutraceutical, and pharmaceutical...

Consultant in Computational Modeling. Drug Design, Proteins, Small Molecules, Genetics, Machine Learning, Artificial Intelligence, Bioinformatics and Biomedicine, Materials Discovery, Robotics & ContrSummary  Drug discovery consulting and research and development in Biomedicine. Providing over ten years in biomolecular computational methods (small molecules and proteins, proteomics, genetics).   Drug Discovery and Biomedicine - Health  High throughput virtual screening and docking. Drug candidate identification. QSAR (Quantitative Structure Activity Relationship) and QSPR (Quantitative Structure Property...

Architect - Forensic Architect and Expert Witness with experience in mold investigation and remediation.Mold investigation and remediation.Construction Industry Arbitrator, AAA.Remediation of building envelope, roof, masonry, and restoration.NYC local law 11-68 and multiple buildings expertise.NYC building code and zoning code expert.Expert Witness ExperienceConversion of an abandoned school to private offices.Local Law 11-68 case, NY.Identified design defects of a hotel.Undisclosed Company, 1968 - PresentPrincipal, 2009 - PresentProvidi...

Medicinal chemist and Pharmaceutical Technology Consultant with Expertise in Drug Research, Drug Formulation, Drug Analysis, Drug Synthesis and Purification, In-Vitro, In-Vivo (Efficacy and Pharmacokinetics) and Dosing RoutsDiscovery and development of novel human therapeutics for: Anti-infective, anti-inflammatory and neurodegenerative diseases.Development of antibacterial clinical candidates, and the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.Drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics) testing, dosing routs, formul...

Appropriate Accurate Data for Clients To Support Legal Claims in HPLC, UPLC, Calibration, Investigation• X HPLC (High Performance Liquid Chromatography and UPLC (Ultra Performance Liquid Chromatography). Assay and impurity analysis for APIs and finished products. Method development and validation. KF titration for water content. GC (Gas Chromatography) with FID (Flame-Ionization Detection), ECD, TCD, NPD for residue detection. GC/Headspace with FID for volatiles. cGMP (Current Good Manufacturing Practices) compliance. Lab Investigations and reports. Safety practices in the lab Controlled substance handling and disposal as per...