Regulatory Actions

Interfacing with Regulatory Bodies

Representing clients during an FDA Inspection

Mitigation of 483 and Warning Letter observations

Responding to a Warning Letter or 483

Developing Recall and Field Action strategies

Managing Correction and Removals
Regulatory Actions
    Beyond Quality & Compliance
Our services are
founded on the
following tenets:  
due diligence,
integrity, and a
passion for
Value added creative solutions for your business