“There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, ***” is the standard language in 70% of agency inspectional observations. This clearly shows the importance of a robust investigations program for any drug, device, biologics, excipient or combination products manufacturing firm.

Our team of Industry and ex-USFDA SMEs have a combined 200 plus years of expertise in ‘Quality Investigations’, and they have delivered multiple thousands of release and retrospective investigation reports with teams ranging in size from single digit to 100+. Our success in conducting, analyzing and defending an investigation comes from an in-depth understanding of regulation, product, process, people, culture and compliance at every client site. Our diverse and experienced SME team works on integrating with our client teams with an end goal of knowledge transfer for sustainable system broad improvement. Our partnership ensures that your entire team (across the enterprise) gains the required knowledge to build and sustain continuous improvement in investigating failures/discrepancies.