"Mark Heller is tops in the field of FDA Law."
"Mark is an amazingly talented and effective lawyer. He is experienced, attentive, timely, articulate, creative, smart, and, most important, gets results. There is no one else I would want to work with on a regulatory matter in front of the FDA.
Mark is also a delight to work with. We have worked together for more than 10 years on a number of different matters and I have come to know him well. Mark has a fantastic sense of humor and can make stressful situations a bit more bearable. He also always brings his "A" game and inspires confidence in his clients.
"Mark has been a trusted friend and invaluable advisor to us. He is responsible for obtaining our Protocol Agreement with FDA, Expedited Review designation of MelaFind, and for facilitating the implementation our QSR procedures. His knowledge of FDA and the approvals process has been critical to us in determining the optimal product development strategies that we have undertaken. Mark has the ability to think strategically, which means he seeks first to understand the needs of our company in suggesting appropriate courses of action. Mark's self-effacing and low-key style belies his professionalism and tremendous experience in the industry. It is an honor, pleasure, and privilege to continue to work with him."
"Our company has used Mark Heller for more than 15 years to assist us in regulatory matters involving the FDA, and for advice regarding public policy. We have found his knowledge of the statutes and regulations governing medical devices, and the actual operations of the FDA, to be unparalleled. "