Remediation & Regulatory Crisis Support

EMMA leads structured, credible responses to FDA Warning Letters. We perform root cause analysis, develop remediation plans, and manage agency communications. Our team ensures responses are defensible and executable. We focus on restoring regulatory confidence. This accelerates resolution and recovery.

We support organizations operating under consent decrees or similar enforcement actions. EMMA provides program leadership, remediation execution, and oversight support. Our team coordinates across quality, regulatory, and operations. We focus on sustained compliance. This supports successful decree exit.

EMMA prepares organizations for regulatory inspections through targeted readiness programs. We conduct mock inspections, gap assessments, and coaching. Our team focuses on execution and confidence under pressure. We address both systems and behaviors. This improves inspection outcomes.

We provide hands-on support during enforcement actions and regulatory escalations. EMMA manages remediation planning, execution, and authority interactions. Our team focuses on clarity, accountability, and speed. We help organizations regain control. This minimizes disruption and risk.

EMMA designs and leads large-scale remediation programs in high-risk environments. We provide governance, execution management, and regulatory alignment. Our team ensures sustained improvement beyond immediate fixes. We focus on long-term compliance maturity. This delivers durable results.

We serve as independent oversight partners for regulators, boards, and leadership teams. EMMA provides objective assessments, progress monitoring, and reporting. Our team brings credibility and regulatory experience. We focus on transparency and accountability. This supports trust and resolution.