Our support spans the full lifecycle of a consent decree—from initial interpretation through certification and long-term compliance. We typically organize our work around four key phases aligned to decree expectations; however, this approach can be adapted to fit your specific situation.
Phase 1: Decree Interpretation and Launch
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Analyze decree terms and obligations
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Develop or refine the required work plan
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Establish PMO infrastructure and milestone tracking systems
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Support FDA negotiations and timeline discussions
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Identify required third-party expert roles and begin coordination
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Phase 2: Remediation and Quality System Remediation
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Redesign and rebuild quality systems (QMS, training, CAPA, supplier, validation)
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Perform gap assessments across facilities, processes, and documentation
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Create or update validation master plans
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Address organizational structure and governance expectations
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Implement interim controls to maintain compliance during transition
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Phase 3: Independent Review and Certification Prep
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Coordinate with decree-appointed or FDA-accepted independent expert
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Support the generation of evidence packages for certification
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Conduct internal audits, mock inspections, and dry runs
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Perform data integrity verification and system validations
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Finalize and submit certification readiness documentation
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Phase 4: Post-Certification Monitoring & Sustainability
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Develop systems for ongoing compliance monitoring
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Execute long-term cultural transformation initiatives
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Define KPIs and dashboards to demonstrate sustained control
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Support follow-up audits and reporting cadence to the FDA
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