We specialize in planning and executing comprehensive remediation projects. Our team of industry professionals and former FDA personnel work hand-in-hand to uncover the root cause of compliance issues, remediate them, and implement the necessary measures to safeguard their reputation for quality both now and in the future.
Quality system failures rarely happen overnight. They're often the result of accumulated gaps, outdated processes, inadequate resources, or rapid growth that outpaces infrastructure. Whether triggered by regulatory observations, internal audits, product failures, or proactive assessments, these systemic issues demand comprehensive remediation that goes beyond quick fixes.
The stakes are high. Inadequate remediation can lead to escalating regulatory actions, product holds, facility shutdowns, and damaged reputations. Yet many organizations struggle to balance the urgency of immediate corrections with the need for sustainable, systemic improvements. They patch problems without addressing root causes, implement changes without considering interdependencies, or create documentation that satisfies regulators but doesn't reflect operational reality.
We bring decades of experience transforming compromised quality systems into robust, compliant, and efficient operations. Our remediation specialists—including former FDA officials who've evaluated hundreds of quality systems—understand both regulatory expectations and operational constraints. We don't just fix problems; we rebuild foundations, strengthen processes, and embed sustainable compliance into your organization's DNA.
Failing to address concerns highlighted in FDA 483s and FDA warning letters can threaten your product pipeline, or worse, result in a recall, import ban, detention, or product seizure—damaging your global supply chain, financial well-being, and reputation. If you have received Form 483 Inspectional Observations, warning letters, or any other enforcement action from regulating agencies, we have the resources, experience, and processes required to resolve those issues quickly and effectively.
Our active remediation model goes beyond consulting to solve a variety of compliance problems while offering ongoing project management and training services each step of the way. Once remediation is complete, we plan, implement, and audit your quality system to ensure regulatory compliance is maintained well into the future.
One of the biggest challenges of remediation is exposing problems that may be completely unknown to you. Even with a capable in-house team, attempting to uncover systemic issues and creating a plan to correct them presents considerable challenges, even for large manufacturers.
Third-party remediation professionals offer a fresh perspective while working diligently to analyze gaps, identify root causes, resolve compliance problems, and communicate your efforts to regulators effectively.
Here's why 17 of the top 25 life science companies call on us for remediation:
Our resources can be utilized to meet the wide range of remediation requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.
Please contact us to learn more about fulfilling specific remediation support needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.
Proprietary talent selection of former FDA and industry professionals amplified by a corporate culture of responsiveness and execution.
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