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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Rapid Process & Procedure Harmonization

Clinical, Medical, and Regulatory functions for eight operating companies of the world’s largest medical device company aspired to harmonized processes and procedures within a 6-month period.  The company had largely been built by acquisition and had to complete the project on time due to compliance-related issues.
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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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Clinical Process Roadmap

A global medical device company with clinical operations staff in multiple locations that had grown through acquisitions wanted to harmonize their SOPs into a single repository.
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