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