A Positive Outcome From An FDA Inspection Conducted At Frontage’s Biologics Bioassay Lab
We are pleased to share with you a very important milestone for Frontage’s Biologics Services business.
The FDA conducted an unannounced inspection of our Biologics Services from April 3-7, 2017. The inspection was directed at a study supported by the biologics group for bioequivalence based on pharmacodynamics biomarkers determined by ELISA. This was our first Biologics FDA inspection and there was no 483s issued. The FDA also selected an LC/MS/MS bioequivalence study for surveillance.
The outcome of this inspection was very good, demonstrating strong compliance and solid scientific processes that our team put together in support of our sponsors’ projects.
We feel extremely proud of this achievement. Thank you all for your support!