Crisis Management
Responding to FDA enforcement actions (483 and warning letters) requires an expert understanding of FDA quality systems and compliance regulations.
Responding to FDA 45 day Letters, Submitting Medical Device Reports for deaths or serious injuries, initiating a recall or a correction and removal requires not only an expert understanding of FDA quality systems and compliance issues but also how to effectively manage these issues so as not to disrupt the entire organization. Realistic Quality Solutions offers a complete array of professional advisory and consulting services specifically designed and developed to successfully resolve the most common and challenging FDA compliance issues.
