interested in learning more about Regulatory Affairs in the biotech and life sciences industries?
Welcome to SDRANSDRAN is a nonprofit organization dedicated to supporting our members through various educational and development programs for medical device and pharmaceutical industry professionals.
UPCOMING SDRAN EVENT
November 18, 2026
NOON - 1:00PM PST
Rare but Regulated: Orphan Drug Pathways
in the US & EU
Featured Technical Session: Join SDRAN for a deep dive into orphan drug regulatory strategies, pathways, and global frameworks.
Dr. Natalia Pripuzova holds a Ph.D. in Virology and MS in Biology (Moscow State University, Biological Department). Since 2006 Natalia continued her scientific career in the United States at the National Cancer Institute (NCI, NIH, Bethesda) and then at US FDA, Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER. She is the lead author of over 15 scientific publications, including a book chapter on quality monitoring of induced pluripotent stem cells (iPSC) by using quantitative proteomics and Alliance for Regenerative Medicine (ARM's) Article on managing process residuals in cell therapies.
Since 2013 Natalia had focused precisely on Regulatory Science and CMC development within CBER, FDA. Since 2015, Dr. Pripuzova served as Product Quality (CMC) Reviewer at the Office of Pharmaceutical Quality, US FDA, CDER, where she completed review of multiple original BLA, IND phase II–III, pre-BLA packages, and post-approval supplements and participated in several Pre-License Inspections (PLI) of drug product and drug substance manufacturing facilities across USA. In 2017 Natalia transitioned to industry and joined JSC R-Pharm, Moscow, as Head of International Regulatory CMC to support worldwide Ph. 3 trials and promote the company's product portfolio towards international expansion. During the recent years Natalia held positions of Director (ADC Therapeutics, San Mateo, CA) and Head of Regulatory CMC (Shoreline Biosciences, San Diego, CA) promoting the development of ADCs (pre-clinical through BLA and post-marketing stages) and iPSC-derived allogeneic CAR-NK cells (early pre-clinical to Ph. 1 clinical stage).
In 2021 Natalia founded NPDK Bioconsulting, a Regulatory CMC consulting firm, aiming to promote the development and commercialization of various biotechnology and pharmaceutical products. As a founder of a consulting firm, she continues the Regulatory CMC support of US-based and international small and mid-size biotechnology companies. She helps clients to initiate early engagement with the US FDA, efficiently navigating the product and process development CMC landscape, and aligning development programs with current FDA and EMA regulatory frameworks.
2026 RAC Preparatory Courses — Now Enrolling!
Join SDRAN's live and also recorded, instructor-led RAC Prep Study Groups and prepare for the Regulatory Affairs Certification (RAC) exam.
Enroll anytime during the course. If you miss a live session, you'll receive full Zoom recordings (available for 6 months) so you can catch up at your convenience.
2026 RAC Device Preparatory Sessions
Schedule: Tuesdays, 6:00–8:00 PM (Pacific)
Dates: July 7 – August 25, 2026
2026 RAC Drug Preparatory Sessions
Schedule: Wednesdays, 6:00–8:00 PM (Pacific)
Dates: July 15 – August 26, 2026
General Info
Our Mailing Address:
SDRAN
P.O. Box 927595
San Diego, CA 92192-7595
MEMBERSHIP
The SDRAN membership fee is:
$55.00 for 12 months
Get In Touch
MAILING ADDRESS
SDRAN
P.O. Box 927595
San Diego, CA 92192-7595