Remediation Services Quality System Remediation Services

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.

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When quality systems fail, every day counts

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 They're often the result of accumulated gaps, outdated processes, inadequate resources, or rapid growth that outpaces infrastructure.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.

Our quality system remediation services include:

  • Comprehensive QMS gap analysis and root cause determination
  • Risk-based remediation planning with prioritized action items
  • Quality system redesign and optimization
  • SOP development, revision, and harmonization
  • Process flow mapping and standardization
  • Quality metrics and KPI development
  • Management review and quality governance restructuring
  • Quality culture assessment and transformation
  • Training program development and competency verification
  • Effectiveness checks and sustainability planning
  • Interim quality leadership during transitions
  • Mock FDA audits to verify remediation effectiveness
  • Form 483 and warning letter response and recovery

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The need for expert remediation support

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 approach to compliance remediation

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.

Our 4-Step Approach to Remediation

  1. Analyze observations and choose the quality investigation model best suited to thoroughly understand the compliance issues at hand.
  2. Launch an internal investigation with the assistance of key stakeholders to assess all affected processes and reveal the root causes of noncompliance.
  3. Draft a comprehensive remediation plan and assure agreement by all stakeholders.
  4. Implement agreed-upon corrective and preventive actions with the appropriate amount of supervision and monitoring.

The benefits of partnering with a remediation expert

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:

  • Former FDA perspective: Our team includes hundreds of former FDA officials who understand exactly what regulators expect.
  • Proven methodologies: Risk-based approaches that prioritize critical gaps while building long-term compliance.
  • Operational expertise: We balance regulatory requirements with business realities.
  • Sustainable solutions: Changes that stick because they're practical, understood, and embraced.
  • Total Quality Guarantee: Your success is guaranteed, or we'll make it right.

Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management of Client
  • Total Quality Guarantee

Contact us and get the conversation started.

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.