About Us

Since our inception in 1999, QIS FDA Consulting has developed a reputation for success. Our commitment to client satisfaction has been the core value of our company which has resulted in a loyal client base.


Donna Hartzfeld
Dr. Donna Hartzfeld

For over two decades, QIS has designed proactive strategies to assist companies in reaching successful regulatory milestones in their drug and device approval process. Founder and President, Donna G. Hartzfeld, Ph.D. has over 25 years of Quality and Laboratory compliance experience in API, pharmaceutical, medical device, combination products, biologics and dietary supplements industries.

Dr. Hartzfeld holds a doctorate degree in PhotoOrganic Chemistry from Arizona State University. Her thesis research was multi-disciplinary incorporating elements of biochemistry, organic synthesis, analytical analysis and physical chemistry to study photoinduced pyrimidine dimer radical anion splitting in DNA Photolyase model systems to elucidate the enzymatic mechanism of electron transfer in UV-damaged DNA repair processes. Techniques utilized were organic synthesis, NMR, MS, X-ray, UV/VIS, HPLC, steady-state and time-resolved laser fluorescence spectrophotometry and resulted in several publications.

During her Doctoral studies, she served as a USA representative at the NATO-Advanced Study Institute School of Photobiology in Medicine at Sardinia, Italy, participated as an invited Researcher at California Institute of Technology in Pasadena, California, inducted into the Academic Honorary Chemical Society of Phi Lamba Upsilon (PLU), and was recipient of the National Scholar of the Year Award from the National Professional Chemical Fraternity, Alpha Chi Sigma (AXE) in 1994 as a result of her cutting edge research activities.

Dr. Hartzfeld really enjoys consulting with companies and working on different products to help achieve their market and commercialization successes.  She loves meeting individuals in the field and working with all different genres of scientists , engineers, business careers. She loves teaching, mentoring and transferring her knowledge to others as a way of ensuring companies manufacture safe and effective products. 

Dr. Hartzfeld has two children and often can be found sitting at a sports stadium in her spare time watching her children play or out trying a new adventure with them.  

An Extension of Your Team

We build and foster relationships through meaningful collaboration and commitment. We cost-effectively optimize the client-consultant interface to perform as an extension of your team. Our ability to navigate smoothly through distinctive company cultural nuances allows us to accomplish our high excellence by integrating ourselves into the clients’ compliance goals and business objectives to seamlessly provide an array of services. Flexibility, insight and accuracy are combined with our regulatory and scientific expertise to ensure we deliver excellent professional quality and compliance services.