Quality Consulting Services

Sajjadi Consulting brings technical expertise and broad based experience to organizations involved in the development of complex biologic products. We focus on helping clients identify product specific quality attributes and deliver high quality data packages internal and external decision makers to enable successful regulatory filings.

Controlling and communicating measurement uncertainty in results is critical to mitigating risks throughout the process. From early phase research through to establishing lot release specifications for safety, purity, strength, identity and potency, unexpected findings must be investigated. Assay design, development and validation studies are integral to understanding the critical quality attributes of a product and statistics guide the generation, analysis and review of scientific data to support regulatory filings.

Areas of Expertise

Potency assay design, development and validation
Development and justification of phase appropriate lot release specifications
Chemistry, Manufacturing and Control (CMC) support
- Regulatory submission review
- Responses to FDA queries
- Audit and evaluation of supporting data and documentation
Investigations into product quality and assay issues
- Out of specification results
- Unexpected outcomes in preclinical or clinical studies
- QC controls trending

What Our Clients Say

“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.”

Research and Development Manager, Assay Development, AGTC

“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!”

President, Statistical Services Company, CA

“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.”

Associate Director, Academic Stem Cell Research Center, CA

“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!”

Director, Global QA and CMC, Cell and Gene Therapy Company

“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.”

VP, Program and Alliance Management, Gene Therapy Company

“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.”

Life Science Networking Professional

“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.”

Senior Director Assay Development, Global Biotechnology Company

Email: nancy@sajjadiconsulting.com
Phone: 703-727-9195

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