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.
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
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.