How To Prepare For A Remote Regulatory Inspection

By Tim Sandle, Ph.D.

There’s no doubt that the COVID-19 pandemic caused numerous changes to the pharma industry, and the advent of remote regulatory inspections was arguably one of the most significant. To accommodate this new approach, both parties — regulatory inspectors (e.g., FDA) and pharma/biotech/medical device companies — need to make changes relating to technology and culture.

Given that this model will continue, to an extent, postcoronavirus, it is important that organizations prepare for remote inspections.