We relied upon Mark to provide us with an exceptionally high quality out-sourced compliance function that was seamlessly up and running almost overnight. His obvious command of all FDA pharmaceutical and device legal issues and his exceptional presentation skills gained the immediate respect and trust of the entire commercial team, senior management and our board of directors. In light of the expertise and real independence that Gardner Law, as an outside legal resource, can provide to internal compliance officers, I would seriously question the paradigm of looking to any other business solution to establish a fully operational compliance function, and am happy to unequivocally recommend Mark for any of your compliance needs.
Thomas McCracken, former VP, General Counsel, Secretary and Compliance Officer of a publicly traded pharmaceutical company
With all the demands on Executives in the Med Device space these days, it’s nice to have a partnership with Gardner Law. Mark brings a seasoned, practical approach to all our Compliance, Sunshine, Clinical, Regulatory, Advertising and Promotional Reviews. Mark’s experience in the medical industry prior to his law practice provides unique insights to help support our business needs.
Brian Scovil, Sr. VP of Operations & General Manager at Torax Medical, Inc.
Mark has been an invaluable resource to Spirox as an emerging medtech company, in our transformation from development to commercialization. He has made sure we have the highest level of compliance – by amending or adding policies and procedures, training our workforce to them, and always being accessible as new issues have arisen. He has allowed us to be doing things the right way, without losing our agility as a start-up.
Neil Hattangadi, M.D. President & COO at Spirox, Inc.
We have worked with Mark for a number of years regarding regulatory/compliance matters and find his work to be of high caliber. He has a practical approach to issues and questions, no doubt because he brings both legal training and a business background to problem solving. His previous business experience makes his advice even more applicable to our matters.
William Bryant, Chief Financial Officer & General Counsel at QOL Medical, LLC
We have utilized Mark Gardner for all of our FDA legal and regulatory needs over the past few years. Mark has provided prescient advice and consultation services with respect to all FDA issues we face, for which we are grateful. In my opinion, Mark’s prior in-house experience is invaluable to his ability to provide not only sound advice, but also practical advice that can be understood and implemented by our businesspeople.
John Maraia, Vice President & Deputy General Counsel at Toyota Tsusho America, Inc.
Mark Gardner’s knowledge and responsiveness have increased our confidence in being compliant with the myriad of laws that affect life sciences and medical device and diagnostics companies on a daily basis. He has deep legal and domain knowledge, is truly client-focused and is practical. In addition, he is a joy to work with. I can highly recommend Mark Gardner to any company operating in any part of the medical and healthcare industries.
Julie Brooks, Executive Vice President, General Counsel and Secretary at Veracyte, Inc.
I rely on Mark’s guidance for complex compliance matters. He brings the combination of real-world business know-how and insightful regulatory experience in a very approachable, practical style.
Robert Buehler, CCO at Respiratory Technologies, Inc. (RespirTech)
We have experienced Gardner Law as a professional partner. Services provided are well-founded and quick in implementation.
Nathanael Küchle, Financial Controller, Heinz Kurz GmbH
I’ve worked with Mark across multiple medical device companies and found him to be efficient, effective and appropriately creative. In his capacity as a consultant to the business he seeks to understand our objectives and to help us reach an outcome that accomplishes our goals while assuring that we are compliant where clear regulations and guidance exist. I particularly appreciate his relevant past experience in the device industry where he served in a customer facing capacity. Mark understands what I’m trying to do.
Mark Stultz, Senior Vice President at SPR Therapeutics, LLC
I met Mark Gardner at a presentation he gave on the Sunshine Act about 5 years ago. At that time, he cost-effectively helped me create a complete Sunshine Act reporting and Compliance program for my company from scratch, which I have since used with my current company. Over the past 5 years, I have found him to be very pragmatic and helpful when it comes to FDA labeling and contract negotiation in balancing risk and compliance with business needs, and has been available and efficient. Since I have utilized him in two small start-up companies, it has been refreshing to work with an attorney who actually recommends ways to save me money. I would recommend Mark without reservation to any medical device company needing regulatory and contracting assistance. He is a true professional who cares about his clients.
Kim Stebbings, U.S. President at DYSIS Medical, Inc.