Plan and execute effective remediation projects with the help of experienced industry professionals.

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.

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.

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.

Our Proven 4-Step Remediation Process

  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.

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.

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.

Contact The FDA Group today for a Remediation consultation.