"Dr. Donna Hartzfeld, and her company QIS, have been consummate professionals in every task. She has proven not only to be extremely knowledgeable technically, but also an expert in client relationship management. Dr. Hartzfeld is the first person I call whenever I have need of a qualified and dedicated scientist." John Little, Director of Operations, Arizona Manufacturing Extension Partnership
“Donna has been both adviser and regulatory consultant to Mission3. In both capacities she has been professional, knowledgeable, and thorough. Her ability to find the right answer and do work with incredible level of quality makes her an incredible asset to any team. She is personable and easy to work with.” -Dirk Beth, President, Mission3, Inc.
“Donna has provided timely and effective quality management consulting to my firm over the years. She is both very knowledgeable and personable, making interacting with her productive and enjoyable.”- Hal Siegel, hired Donna as a Business Consultant in 2005, and hired Donna more than once
"Certainly when you retain a regulatory affairs consultant, you look for subject matter competence. Donna goes well beyond that, offering company-specific advice, understanding time sensitivity, and providing the care needed in a start-up environment. I strongly recommend her.”- Lubna Ahmad, CEO, Invoy Technologies. LLC
“Dr. Donna Hartzfeld is an experienced consulting professional who has effectively led many teams in the areas of quality systems development, validation, and warning letter response. I have worked with Donna on multiple past projects in the medical device, OTC, and pharmaceutical industries and I would work with/for her again without reservation. She is a valuable asset to any project requiring technical knowledge, regulatory knowledge or skilled leadership to meet critical task deadlines.” -Edward McKenzie, Senior Consultant, Quintiles Consulting
“Donna is a subject matter expert in FDA regulatory compliance. She has performed in various consulting capacities for many clients and has a reputation for getting the job done thoroughly and with a high client satisfaction. It has been a pleasure to work with her and I highly recommend Donna for her knowledge and professionalism.” -Warren Opfer, Principal - Life Science Services International (LSSI)
“QIS, Inc. was actively engaged in performing cGLP audits for our organization. In the midst of executing that task, QIS, Inc. eagerly switched gears and was instrumental in helping us reach our goal to submit the grant proposal on time. And the grant proposal proved successful for us” - Michael Wilhelm, CEO and J. Fermanis, CFO, ImmuneRegen BioSciences, Scottsdale, AZ
“We recently worked together as part of a team to improve and reduce Lab Investigations for a client. Dr. Hartzfeld showed good problem solving skills and excellent technical competence in doing the Lab Investigations. Her communication skills in writing and verbally are very good.” J. Wiskerchen, retired FDA Laboratory Director, Seattle District