Whether your company is facing an FDA 483, Warning Letter or Consent Decree, QualityHub can help your leadership team create and execute the plans to overcome your company’s FDA regulatory compliance challenges.
Finding your gaps is just the beginning. QualityHub’s FDA regulatory compliance experts can help you accomplish the work needed to bring your organization into compliance.
We can provide the needed quality system project (strategic) leads, project managers, and subject matter experts who can help guide, coach and move the critical project along.
For more tactical work, our associate consultants can help execute on quality system deliverables and documents. Our interim quality professionals solution can provide interim management and other personnel to ensure the work continues throughout the process of addressing your FDA 483, Warning Letter or Consent Decree.