Reglera

Reglera is a specialized regulatory compliance and quality assurance consulting firm focused on the medical device and human tissue (HCT/P) sectors. The company provides comprehensive services including quality management system (QMS) development, FDA 510(k) submissions, regulatory audits, and tissue bank management. Founded in 2001 and headquartered in Colorado, Reglera was acquired by Eurofins Scientific in 2015 to bolster its medical device testing and consulting capabilities. It serves as a strategic partner for life science companies navigating complex global regulatory landscapes. The firm is particularly recognized for its expertise in 21 CFR Part 1271 regulations and its ability to provide outsourced quality solutions for small to mid-sized biotech firms.