Remediation Support

We specialize in planning and conducting comprehensive remediation projects. Our team of former FDA and industry professionals work hand-in-hand with pharmaceutical, biologic, and medical device manufacturers to uncover the root cause of compliance issues, remediate them, and implement the necessary measures to safeguard your 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 Corrective and Preventive Action (CAPA) plan and assure agreement by all stakeholders.
  4. Implement agreed-upon corrective and preventive actions with the appropriate amount of supervision and monitoring.

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

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

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.

Postmarket Surveillance Auditing & Remediation

Inefficient or inadequate processes within postmarket surveillance programs can lead to large complaint file backlogs and other problems that put FDA-regulated manufacturers and patients at risk. Our experienced postmarket surveillance experts begin by reviewing an existing gap assessment or performing systems audits and analyzing a statistical sample of your backlog and other impacted areas.

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Read our brochure to learn more about remediation support and our full range of life science resourcing capabilities.

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Contact us today to learn more about our remediation support services.