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Drug Development for Small Molecules, Biologics and Devices

  • Provide strategic support for licensing and Due Diligence activities

  • Conduct Gap Analysis for new partnerships and acquisitions in Oncology, Metabolic Disorders, Neurodegenerative/Pain and Cardiovascular Disease

  • Provide Nonclinical Strategy for early or late development of small molecule programs,

  • Provide Safety and Risk Assessment 

  • Provide Scientific Program Management including Contract Research Organization Interactions, Study Monitoring, Study Design and Study directing;   Edit and review study protocols;   Review and edit study reports 

  • Manage GLP Studies (Toxicology, Safety Pharmacology, Pharmacology, Assay Validation)

 

Author and/or Review Regulatory filings (US-FDA, EU-EMA, Health Canada, Australia TGA, CFDA)

  • Nonclinical Sections of CTDs, INDs, CTAs, DSURs and IBs

  • Provide research , literature searches and White Papers to support filings

Services

 

Principal, Stephanie Greene, PhD

Drug Safety Scientist 

  • Nonclinical Safety - Strategy, Safety, and Risk Assessment

  • Licensing, Due Diligence, Gap Analysis 

  • Scientific Program Management including Contract Research Organization Interactions,

  • Study Monitoring, Study Design and Directing

  • Clinical Pharmacology

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