Over twenty five years of management experience in clinical development and research in academia and industry. Diverse clinical training with knowledge or expertise in immunology, autoimmunity, renal disease, transplantation science, intensive care, infectious disease, oncology, ophthalmology, brain death and end of life issues, and the practice and art of medicine. Expert in pharmacovigilance, clinical development phase I/II/III and IV, and post marketing and commercialization experience with generic, biologic and device products.
Vision to find creative and efficient solutions for your consulting needs
Multiple successful medical/regulatory filings including BLA, NDS, IND, IDE, 510K, MTA and orphan submissions with significant extensive interactions with FDA, Health Canada, European regulatory authorities, China, and India.
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