Compliance Remediation

Turning Regulatory Fallout Into Strategic Opportunity.

When regulatory trouble hits, whether it’s an FDA-483 inspectional observation form, a warning letter, or a full-blown consent decree, your company needs more than advice – it needs transformation. That’s where QualityHub’s compliance remediation consultants come into play: equal parts regulatory expert, crisis manager, and quality system architect.

Compliance remediation isn’t just about cleaning up after an inspection. It’s about restoring confidence with regulators, patients, customers, and other stakeholders. Our experts don’t just “fix the gaps.” They rebuild the systems that allowed the issues to happen in the first place and leave your organization stronger, leaner, and ready for regulatory inspection.

Whether you’re a start-up navigating your first post-market hiccup or a global enterprise facing significant enforcement action, QualityHub remediation consultants act as embedded partners, diving deep into your systems, identifying weak links, and working side-by-side with your teams to rebuild from the inside out.

In addition to hands-on remediation, we help train and upskill your full-time employees, ensuring your internal teams are empowered with the knowledge and capabilities needed to sustain compliance and drive continuous improvement.

Ready to move from remediation to resilience? Learn more about our compliance remediation services listed below so your company can secure the present, fix the past, and shape the future.

QualityHub’s compliance remediation process begins with a comprehensive review of your company’s regulatory findings. We analyze inspection reports and/or enforcement letters in detail to understand not only what deficiencies were cited, but also the broader systemic issues behind them.

As part of this initial phase, we perform a baseline audit (or audits) of your Quality Management System (QMS) to establish a clear understanding of current compliance status and identify any gaps not captured in external findings. This audit provides a foundation for a full diagnostic assessment and helps prioritize areas for immediate remediation. The process often involves reviewing internal documentation, quality records, audit reports, and interviewing staff to understand how the organization’s processes function day-to-day – not just how they’re documented to work.

This gives our experts a clear picture of the compliance landscape across the organization and reveals whether the issues are isolated or indicative of systemic problems, such as a weak quality culture, poor training programs, or inadequate management oversight, to name a few. In combination products, for example, they would pay close attention to whether the company properly integrates both drug and device requirements under 21 CFR, Part 4 in the US for the FDA.

And when it comes to drug manufacturing, our consultants closely evaluate adherence to FDA requirements under 21 CFR, Part 211, which outlines current Good Manufacturing Practice (cGMP) for finished pharmaceuticals. This includes assessing controls over production and process validation, quality control procedures, recordkeeping, laboratory practices, and the adequacy of facilities and equipment to ensure consistent product quality and regulatory compliance.

Once the scope and scale of the issues are understood, QualityHub consultants facilitate or conduct root cause investigations. This is a critical step: without a correct understanding of the root causes, any corrective actions are likely to be superficial or temporary. For example, if a pharmaceutical manufacturing site has repeated issues with contamination or failed batches, the root cause may not just be poor cleaning procedures, but a deficient training program or broken quality oversight that allowed those practices to persist.

After root causes are identified, we work with your company to create a comprehensive remediation plan. This plan outlines specific corrective and preventive actions (CAPAs), the timeline for their implementation, and how their effectiveness will be verified. The plan often includes revisions or creation of standard operating procedures (SOPs), retraining staff, redesigning processes, or implementing a new Quality Management System (QMS), among other potential activities.

Regulatory agencies, particularly the FDA, often expect this plan to be risk-based, meaning the company should prioritize actions that mitigate the highest risks to patient safety or product quality. Our highly skilled consultants are instrumental in ensuring the remediation strategy meets these expectations and is realistic given your company’s finite resources.

During the execution phase, QualityHub consultants are often deeply embedded in the company’s operations. They may temporarily lead remediation project teams or coach internal leaders on how to effectively drive changes. For example, in a medical device company cited for insufficient design controls, our experts may help redesign the entire design history file (DHF) process and ensure the requirements of 21 CFR, Part 820.30 are fully met for the FDA.

Meanwhile, in a pharmaceutical plant under scrutiny for data integrity issues, our consultants might assist in performing a data integrity audit across the lab or production systems, help implement audit trails, and train staff in ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).

Our experts also work with validation teams to revalidate critical processes or systems where documentation was lacking or compliance was inadequate. This might include requalification of equipment, cleaning validation, or method validation in analytical labs. Consultants are particularly valuable in managing complex, cross-functional issues that involve both quality and technical teams, especially in biologics or combination products where regulations overlap.

An important but often overlooked aspect of remediation is ensuring that any corrective actions taken are indeed effective. QualityHub consultants will design and help implement effectiveness checks, which may involve audits, process reviews, data trending, or other metrics that demonstrate the improvements are sustained over time. For example, if a company corrected a complaint handling issue, our experts would look for evidence that complaint investigations are now consistently thorough, timely, and leading to appropriate CAPAs.

QualityHub consultants also help prepare for re-inspections or follow-up reviews by regulatory agencies. They may conduct mock FDA inspections, coach executives and staff on how to respond to agency investigators, and develop inspection readiness binders and response protocols. These services are critical to avoid further regulatory escalation and to demonstrate that the company takes its compliance obligations seriously.

In many cases, we are involved in drafting the formal correspondence to regulators, including FDA-483 responses, Warning Letter replies, and updates on remediation status. These communications must be both technically accurate and strategically crafted to regulatory confidence.

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