Josephine Torrente

Expert Guidance Through a Complex FDA Regulatory Challenge

When our small medical device startup received an unexpected and detailed FDA Form 483 following an inspection, we were overwhelmed. The observations threatened to derail our product launch and our company's future. We needed an attorney who not only understood the letter of the law but could navigate the nuanced, practical realities of the Agency. From our first consultation, Josephine Torrente at Hyman, Phelps & McNamara demonstrated a command of FDA regulations that belied her one year in practice. Her background, including her M.S. from UAB, gave her a tangible understanding of the scientific and technical aspects of our case, which was invaluable. Josephine meticulously helped us craft a comprehensive response strategy, focusing on substantive corrections and robust procedural changes. Her guidance was clear, strategic, and always grounded in a deep knowledge of FDA enforcement trends—a clear reflection of the recognition she has earned in this specialized field. The outcome was a complete success; the FDA closed the inspection with no further action, allowing us to proceed. Josephine’s professionalism, responsiveness, and ability to translate complex legal concepts into actionable business steps were exceptional. We have immense confidence in her and her firm.