White Papers

White Papers

Data Integrity and the Pre-Approval Inspection: An Inspector’s Experience

By: John R. Godshalk, MSE, MBA, Senior Consultant

Data integrity has always played an essential role in regulatory application review and cGMP inspections – a trend that will only continue to grow in the coming years.

Zika Virus: The Development of Medical Countermeasures

By: Paul W. Price, PhD, Senior Consultant

The global concern about Zika virus continues to grow as the international community braces for its continued spread.