It was apparently random, although I secretly suspect it was karmic punishment for my lack of imagination in writing the 2019 quality goal. It has been ‘Maintain the quality management system and documentation in inspection-ready form’ for the past 3 years. While we take quality and regulation seriously, our assumption, like that of many early-phase companies, had been that an actual FDA inspection was several years off. I had previously been involved in pre-approval inspections and the questions regarding early studies were always the most difficult to piece together; the team who ran the study had moved on or the asset was in-licenced. For this reason, we had invested in making sure we had a good filing structure from the start and were maintaining the appropriate documentation. It now appeared that these efforts would be put to the test.
This blog was written by Aoife Brennan, CEO of Synlogic, as part of the From The Trenches feature of LifeSciVC.