SciLucent’s staff includes scientific, medical, and regulatory professionals with expertise and experience in all aspects of healthcare product development and marketed product support.
Carl G. Osborne, D.V.M.
New Product Development; Regulatory Strategy; Nonclinical and Clinical Program Development; CMC Program Development and Implementation; Business Development and Operations
Carl Osborne is an internationally recognized expert in drug development, business development, strategic planning and operational process improvement. He has undertaken or overseen numerous due diligence exercises for drug, biologics, and medical devices; helped define business, scientific, and regulatory strategies for development-stage companies; assisted clients in the planning and execution of numerous product development plans, prepared INDs, IDEs, NDAs, BLAs, CTAs, and MAAs; and worked to help companies develop better operational systems (e.g., Project/Program Management, Outsource Management, Compliance Management, etc.). He is a former FDA toxicologist and compliance officer with extensive experience in international regulatory affairs, and quality systems (cGMP, GLP, GCP, QSR,) design, implementation, management, and remediation. Carl’s expertise includes monoclonal antibodies, oncology drugs, neurology drugs, antibiotics, cardiovascular drugs, pulmonary drugs, and gastrointestinal drugs.
