I am an individual with Doctorate in Medicine (MD) with adequate clinical training in internal medicine, Hematology and Oncology, Regulatory, clinical development, and post marketing development efforts. I have gained a broad background and proven success in delivering effective global (FDA, EMA, ANVISA, etc.) regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration. I have served my employer and its clients for 10 years. Specifics are available upon a mutual confidential disclosure agreement (CDA).

Clinical, medical, regulatory, safety, case review, pharmacovigilance, surveillance, drug development, BLA, NDA, phase I- IV, licensing, REMS, and RISKMAP.