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Detection of Adverse Drug Reactions with a Specialized Focus on Neuropsychiatric Adverse Reactions
Expert is a board-certified psychiatrist who runs a private practice that specializes in the identification and treatment of adverse reactions of neuropsychiatric medications. He has over 7 years of experience as a clinical psychiatrist, and has been engaged in drug…
Immuno-Oncology
Core Competencies: - Cancer-biomarker and drug discovery - Biomarkers and biosimilars - Immunotherapy - Tumor microenvironment - Orthotopic animal models of disease - Knowledge about the cancer drug market - Analytical, strategic, and critical thinking - Highly adaptive and team…
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…
Forensic Examination of Questioned Documents and Handwriting
Retired FBI Supervisory Special Agent; 45 years experience as handwriting expert. In private practice since FBI retirement October, 1989 (worked estimated 2,350 private cases since retirement from FBI); 11 years as Forensic Document Examiner at FBI Laboratory (worked thousands of…
Bioanalytics, Chemistry
As an active contributor in the R&D scientific division of both industry and government for the past 20+ years, Expert has had the opportunity to leverage his strong structure elucidation background from graduate school for application in clinical, and forensic…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Pharmaceutical Licensing Partnerships and Intellectual Property Disputes
Summary of Experience: Pharmaceutical who has over 25 years of experience in partnerships and licensing and clinical trials. Involved in all aspects of business partnerships: identification, evaluation, due diligence, negotiations, clinical trials contract drafting and alliance management. Experience in the…
Pet and Vet Industry; Specializing In Pharmaceutical, Food, Treat and Nutraceutical Formulation
Forward-looking, entrepreneurial CEO and Managing Director with stellar, 20+ year record of achievement. Sets core business strategies that deliver major professional and customer demand in competitive markets. Spurs organizational growth and excellence by proactively developing staff; nurturing and fostering strengths…