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Biotechnology, Nucleic Acids, DNA and RNA, and Research and Drug Development
Subject matter expert on biotechnology and nucleic acids with over 20 years of experience. He is an experienced developer of tools for the detection and quantification of both DNA and RNA for diagnostics, and research and drug development. Expert currently…
Drug Delivery Modeling
Expert is an independent modeling consultant from Huntsville, Alabama. Until recently, he was a senior principal scientist in CFD Research Corporation (CFDRC), Huntsville, Alabama. He has a strong background in PBBM/PBPK modeling and simulation methods, CFD, scientific computing, mathematical modeling…
Cannabis Industries
A graduate of Sciences Po Paris and of the United Nations-mandated University for Peace (UPEACE), Expert is a former consultant for the United Nations Office on Drugs and Crime (UNODC) in the Lao PDR and Panama. He is the co-founder…
Scientific, Clinical, Medical, and Regulatory Affairs
Expert is a senior executive and a global biomedical leader with expertise in all facets of basic, pre-clinical, clinical research, and regulatory science for drug, biologic, therapy, vaccine, and medical device development. Expert is a leader in strategic planning and…
Pharmaceutical Regulatory / Technical / Intelligence
Expert is presently associated with an apex drug regulatory body in India as the Asst Drugs Controller and has been associated with the firm since August, 2003. He has a very diverse/extensive experience in the Healthcare Industry and is presently…
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…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Medicinal Chemistry/ Synthetic Organic Chemistry-Research and Patent Litigation
Experienced Medicinal Chemist and Consultant: expert at synthetic organic chemistry, pharmaceutical chemistry, pharmaceutical patent litigation, patent analysis: 1) Eight years of consulting experience, beginning in Jan. 2012, writing expert reports following patent analysis covering obviousness, claims validation, enablement; depositions given.…
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…