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.

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.

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

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.