Rescue and Litigation

Regulatory Rescue 

In instances where compliance challenges have arisen or where regulatory issues require immediate attention, Kinexum’s rescue and salvage services offer swift and effective solutions. We specialize in identifying the root causes of non-compliance, developing corrective action plans, and guiding you through the process of remediation. 

Whether you require assistance with FDA correspondence, remediation of inspection findings, or implementation of corrective and preventive actions (CAPAs), our team is committed to providing responsive support to help you reenter compliance and maintain operational continuity. 

 

Litigation 

Kinexum subject matter experts are available to serve as expert witnesses in aspects of medical product development during litigation.