Case Study: Leading Biotech Company Achieves FDA Accelerated Approval and Inspection-Ready Sites with Advarra

Biotech Organization Partners with Advarra to Become Inspection Ready

Leading Biotech Company, an established biotech organization running global clinical trials to develop better‑tolerated anti‑cancer therapies, needed a partner with proven global GxP expertise and FDA guidance to support inspection readiness. They engaged Advarra (Advarra Consulting) for services including investigator site audits, trial master file (TMF) audits, for‑cause audits, other quality assurance services, and inspection readiness support after three sites were selected for FDA inspection in the same week — one of which required a local‑language observer.

Advarra delivered global GxP and inspection‑readiness support, conducting more than 75 audits since 2018 and eight inspection readiness visits in early 2022, and provided a local language inspection observer for the EU site. As a result of Advarra’s work, none of the inspected sites received a Form FDA 483 and Leading Biotech Company’s market application was granted accelerated FDA approval in 2022.