Compliance & Remediation

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TDP’s Compliance & Remediation service supports pharmaceutical, biotech, medical device and wider life sciences organisations in responding to inspection findings, regulatory observations, warning letters, statements of non-compliance and systemic quality issues.

Our expert-led remediation teams design and deliver pragmatic, risk-based programmes that restore compliance, strengthen Quality Management System maturity and reduce the likelihood of repeat findings. Rather than applying short-term fixes, TDP focuses on true root-cause analysis, regulatory defensibility and sustainable improvement across processes, governance, behaviours and quality culture.

Whether support is required following an MHRA, FDA, EU or other regulatory inspection, or as part of a proactive quality transformation programme, TDP provides calm, structured and credible support during high-stakes compliance situations.

BEST FOR

Organisations responding to critical, major or repeat inspection findings, regulatory observations, CAPAs, warning letters or statements of non-compliance.

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Life sciences companies experiencing systemic quality failures, recurring deviations, weak CAPA effectiveness or quality system weaknesses that require structured remediation.

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Businesses that need expert-led, efficient and effective remediation teams to restore compliance quickly while maintaining supply continuity and operational control.Add here…

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WHAT’S INCLUDED

Inspection finding and regulatory observation assessment, including triage of immediate compliance and patient safety risks.

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Root-cause analysis using recognised methodologies to identify the true source of non-compliance, not just visible symptoms.

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CAPA strategy development, prioritisation, execution support and effectiveness check planning.

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Remediation programme design, including roadmap development, ownership, timelines, governance and escalation structure.

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Quality system review, redesign or enhancement across SOPs, processes, documentation, controls and operating practices.

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Regulatory response support, including inspection follow-up, evidence generation and closure documentation.

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Training, behavioural change and cross-functional alignment to embed sustainable improvements and reduce repeat findings.

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HOW IT WORKS

Assess & triage TDP rapidly reviews inspection findings, regulatory correspondence, QMS gaps and immediate risk areas to understand the scope, severity and potential regulatory impact.

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Plan the remediation programme We develop a clear remediation roadmap with priorities, timelines, ownership, governance and escalation routes aligned to regulatory commitments and operational realities.

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Deploy expert-led delivery teams TDP mobilises efficient, effective teams to support CAPA execution, process updates, evidence generation, cross-functional alignment and remediation delivery.

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Close, evidence & defend We support effectiveness checks, inspection-ready documentation, regulatory closure and preparation for re-inspection or follow-up audit.

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