A renowned biotech company engaged in worldwide clinical trials, committed to bringing efficient and better-tolerated anti-cancer treatments to the market, found themselves facing an intriguing challenge. They sought a partner with a strong background in global GxP services and a successful track record of providing guidance to life sciences companies with global operations, particularly concerning the U.S. Food and Drug Administration (FDA) regulations.
Enter Advarra Consulting, the preferred partner for this biotech firm since 2018. Throughout their collaboration, Advarra has been instrumental in supporting the company's growth during crucial turning points. They have offered an array of services, including investigator site audits, trial master file (TMF) audits, for-cause audits, and various other quality assurance services.
In a recent endeavor, discover how Advarra was able to help the biotech company conduct thorough site inspection readiness activities and receive accelerated FDA approval.