Regulatory Enforcement Action Support

Regulatory inspections from authorities around the world may require pharma biotech companies to respond to specific enforcement actions. Helping you with regulatory compliance is the core of our expertise. Our team includes former U.S. FDA and UK MHRA inspectors and experts with decades of experience helping companies develop strategic plans to address enforcement actions (FDA, MHRA, Health Canada, etc.).

Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues. We can help companies with FDA 483s and warning letters, critical findings from European authorities, product seizure, Application Integrity Policy, consent decrees and import detention.

We develop solutions collaboratively with your firm to affect the necessary change to your organization to achieve a practical yet compliant quality system. Our efforts are comprehensive and sustainable, and prevent future occurrences of similar compliance deficiencies.

We also help companies prior to any regulatory action by evaluating their systems and ensuring that any compliance gaps are addressed.

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