Biotech Submits NDA After Risk-Based Mock Inspection

An emerging biotech company recently collaborated with inSeption Group to take a preventative approach to mitigate risks, identify potential concerns before an FDA inspection, and submit their NDA. The comprehensive risk-based strategy combined various approaches to ensure a thorough examination of all aspects of clinical studies and Quality Management System.

See how the sponsor was able to address gaps within its application by reading this case study.