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.

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 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.

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.