Quality Begins with Caring

With interdisciplinary expertise and over 30 years of professional experience, Nancy Sajjadi helps organizations engineer quality into the development of complex biologic products.  She also guides leaders in the pharmaceutical and healthcare industry in building and maintaining a culture of quality.  She brings added clarity, calm and cohesiveness to talented teams striving to deliver quality products and services to patients.


Quality Consulting -- Assays and Investigations

Quality Consulting—Assays and Investigations

The path to developing a safe and effective biologic product is arduous and expensive. Sajjadi Consulting works with clients to identify the critical quality attributes of complex products and develop corresponding assays to measure them.  We engage with statisticians to enable the generation, analysis, and review of valid data to support regulatory filings and help clients investigate any unexpected results.

Professional Development—Culture of Quality

Human connections are critical conduits in synchronizing the steps necessary to safely and effectively treat patients with biologic products. From research to bedside delivery, the quality outcomes every person deserves, emerge when feedback mechanisms are fluid across the entire process. A true culture of quality reflects a high level of collective concern for others and deep, individual capacities to care.

Speaking—Public and Private Events

An outside speaker can infuse energy, ideas, and excitement into any meeting or organizational event.  Participants and panels can benefit from the unique or orthogonal view of an invited individual. An engaging and enthusiastic speaker can catalyze important conversations, spawn new relationships, and stimulate curiosity toward greater innovation and cooperation.

What Our Clients Say

“In the development of an autologous cell therapy, we engaged Nancy Sajjadi to assist with the qualification of a diverse set of assays.  Given the nature of the product, and the fact that this translational project is supported within an academic medical center rather than a company, we needed someone with unique knowledge and a great deal of flexibility.  Ms. Sajjadi was incredibly effective at navigating all the intricacies, and provided valuable advice to the project.  She was responsive and the whole team enjoyed working with her.  Most importantly, the results of her work were favorably reviewed by both extramural funding agencies and FDA.  We unreservedly recommend her work.”

“I highly recommend this class (Biostatistics for Beginners Course) for any analyst that needs to know whether a result can be accepted or rejected with confidence, or if suitable for the intended use. Nancy Sajjadi has put together a concise, well-presented course. Prepare to be challenged! The open forum small class is conducive to discuss common methodologies, regulatory guidelines, and analytical method validation. A great class as a refresher or to learn something new.”

“To expose students to career options and inspire them to pursue research in microbiology I invited Nancy to speak to students on “The development of Biopharmaceutical Products” at Virginia State University where I taught for 15 years. I warned her in advance that it was not uncommon for students to get up and leave during a talk. I was pleasantly surprised that all students were totally absorbed and stayed for the entire time she spoke. The students found her personal and professional stories very inspiring and felt comfortable approaching her afterwards! I would highly recommend Nancy as a speaker for any group!”

“I recommended Nancy as a speaker to one of my big pharmaceutical clients. They hired her and were impressed enough to invite her back 5 times so far! I have also seen Nancy give talks at conferences. She is enthusiastic, engaging and entertaining in delivering information and ideas that motivate people to act!”

“Nancy Sajjadi is a joy to work with and I have learned so much from her. She taught me that life, work and self-care are not separable. Thank you to Nancy for being so inspiring and insightful.”

“The wellness seminar married mental health with corporate culture and spurred much needed open discussions within our leadership team about moving from exhaustion to work-life balance, finding purpose, and building cohesion. Ms. Sajjadi was masterful at bottom-line thinking and mirroring needs back in ways that brought us insight and direction.  Her quick-witted energy and pointed questions provided great guidance and engaged everyone in thoughtful discussions about what matters in the workplace. We all left more motivated to build and maintain a healthy work culture.”

“We have been working with Nancy for just over a year to optimize several bioassays in preparation for early phase clinical studies.  During this time Nancy not only provided the tools required to design qualification studies as well as data analysis and setting appropriate specifications, but also made sure the team had full understanding of all concepts.  Discussions are always upbeat, focused and informative as Nancy is an expert in her field.  I would highly recommend Nancy as a consultant!”

“I retained Nancy Sajjadi to assist in the investigation of some unexpected and discordant data for a viral vector.  Although Nancy had no direct experience with our viral system, she was quick to understand it and able to devise a series of experiments to elucidate an underlying issue. Throughout the process, she was responsive to my requests to review and discuss data as soon as they became available and to provide well-written reports summarizing the study results in a timely manner.  I have recommended Nancy to others and would certainly reach out to her again if I encounter any challenging CMC issues in the future.”

“Nancy has an incredible ability to take complex material and synthesize it down into what is most important for her audience/clients to know and understand. This rare skill makes her an excellent communicator and teacher.”

“Nancy Sajjadi has decades of experience in development and validation of analytical and bioanalytical assays for large molecules in regulated environments, as well as the quality considerations pertaining to their implementation.  She is second to none in her grasp of the complexities of these assays, the subtleties of making them robust enough for routine use and properly analyzing the data obtained from them. She has presented to FDA, participated in the writing of USP chapters, and published widely on a variety of analytical/bioanalytical topics. Her partnership with Jan Callahan is a perfect complementation. Nancy has the rare ability to translate analytical problems into terms that make sense to seasoned biostatisticians such as Jan; Jan has the depth of experience needed to provide  templates for data analysis that are accessible to bench scientists. I have worked with this consulting team at several companies, always with the highest level of satisfaction, and enthusiastically give my highest level of recommendation.”