Quality in Small Pharma: Stability Testing and Quality Management Systems: Poster Presented at PDA Week 2026.

Small companies face the same regulations as organizations many times their size, but with fewer resources and less specialized departments. This can present challenges for ensuring rigorous data analysis, but also encourage creativity in mapping a pathway to FDA approval of drug products.This presentation explores three topics within Quality and Regulatory Affairs: the Animal Rule, Stability Reports, and implementing electronic quality management systems (eQMS). The Animal Rule is a little known regulatory pathway that highlights one of the ways the United States prepares for public health emergencies, supporting development of medical products that might not otherwise see attention from industry. Stability reports ultimately contribute to module 3 of the common technical document (CTD), and are essential to understanding the expiration dates of drug products and drug substances. Finally, electronic quality management systems (eQMS) support quality activities company-wide, and play a major role in compliance and efficiency in an organization.