Quality Assurance Remediation Support

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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What is Compliance Remediation?

Compliance remediation is the process of recognizing problems, creating a plan to correct and prevent them from occurring in the future, and executing to that plan. This often requires alignment with an experienced remediation partner capable of identifying the root causes of compliance issues, resolving them, and communicating those actions to the FDA.

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.

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

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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.