Mock FDA Inspection

An innovative biopharmaceutical company focused on development and commercialization of medicines to treat renal diseases were in need of an urgent mock Food and Drug Administration (FDA) inspection.
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FDA 483 Action Planning & Remediation

An early stage device company received a 483 with multiple observations after a long two-week BIMO inspection and were in need of strategic support to address findings in a short period of time and develop an action plan for remediation.
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Quick Response Needed for Cause Audit

A small pharma company partnering with a government agency on a clinical program learned that FDA planned to inspect one of their top-enrolling clinical sites in conjunction with a significant finding for another sponsor.
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