Prudentia gets you ready for regulatory inspections. We guide you through inspections. We help you closeout and respond to inspections. Our team conducts mock inspections of case processing, aggregate reporting, and signaling for both pre- and post-approval.
Our team develops a plan to address the gaps and get the organization’s practices and documentation in place. Our team works with your legal, regulatory, clinical, and affiliates to organize a responsive and effective inspection team. Our team develops strategies for addressing inspection findings and keeping regulators continuously updated with the progress of corrective and preventative actions.