Consent Decree & Third-Party Oversight

Pharmaceutical & Medical Device Remediation Services

RCA offers a broad range of third-party oversight and remediation consulting services to guide you through the complexities of a consent decree.

• Independent Third-Party Oversight – Provide impartial oversight to monitor remediation progress, ensuring that corrective actions are executed properly.
• Comprehensive Audits – Conduct in-depth evaluations of operations to identify compliance gaps and areas for improvement.
• Remediation Plans – Develop detailed plans to address identified risks and weaknesses, and oversee the implementation of corrective actions and processes
• Interim Controls – Implement temporary controls to mitigate risks and maintain compliance during the remediation process.
• Project Management – Assign a Project Management Professional (PMP) to lead and coordinate remediation efforts, ensuring timely and effective action.
• FDA Meeting Support – Assist with preparing for and attending FDA meetings, ensuring that remediation efforts are communicated clearly to the agency.
• Quality System Remediation – Develop and implement scalable, defendable quality management systems to meet regulatory standards and resolve compliance issues.
• Mock Inspections / Gap Assessments – Simulate real inspections to identify compliance gaps and prepare for future regulatory scrutiny.
• Risk Assessment & Impact Analysis – Evaluate the potential risks associated with non-compliance and develop strategies to mitigate them.
• Data Integrity Assessments – Ensure data accuracy and traceability, strengthening systems to meet FDA and regulatory expectations.
• Supplier Quality Programs & Quality Agreements – Oversee supplier relationships and ensure that quality agreements are in place to meet regulatory standards.
• Shop Floor Oversight – Provide oversight of manufacturing and operational processes to ensure compliance with quality standards.
• Batch Record Review & Release Support – Assist with reviewing and releasing batch records to ensure compliance with FDA requirements.
• Investigations and CAPA Remediation – Guide companies in conducting investigations into quality issues and implementing corrective and preventive actions (CAPA).
• Regulatory Submissions Support – Provide guidance on preparing regulatory submissions, including 510(k) applications and New Drug Applications (NDAs).
• Training for Inspection Readiness – Offer specialized training to ensure staff and management are prepared for FDA inspections and regulatory audits.
• Environmental Control Oversight – Ensure compliance with environmental control standards in manufacturing and laboratory settings.
• Calibration and Maintenance Oversight – Oversee the calibration and maintenance of equipment, ensuring it meets regulatory standards.
• Non-Conforming Product Oversight – Manage the oversight and handling of non-conforming products to ensure they are identified and addressed in compliance with regulatory requirements.

Keep Your Project Moving Forward Through a Consent Decree

A consent decree is a major challenge but with the right partner, you can navigate this regulatory hurdle and emerge stronger.

We help you resolve compliance issues swiftly and minimize the impact on your business. With RCA as your guide, you’ll regain control and ensure that your company remains compliant moving forward

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