Case Studies: Regulatory Strategy

At QualityHub, we have experience in regulatory strategies for several types of companies and situations. Here are two examples of regulatory strategy case studies to give you some background on that experience.

Before, During & After Consent Decree

Regulatory Strategy Case Study

QualityHub worked with one major medical device company before, during, and after a consent decree. Working with their in-house and external attorneys, we helped develop strategies to address the FDA’s concerns, stabilize their quality system and develop the necessary improvements to the organization and the quality system. During this project, we also were able to provide interim professionals to assist with several positions in the company.

The work involved planning for and attending meetings with FDA, assisting in the formal written responses to the FDA and creating the overall plan/strategy that FDA was expecting to see. Execution of the plan followed on this project—which lasted close to two years. We worked closely with the company’s senior management, in-house and external attorneys throughout the project. For this project, QualityHub was not the certification auditor, but rather the organization helping the company rebuild and reshape their quality system.

Recidivist Warning Letter

Regulatory Strategy Case Study

For a major medical device company, we assisted in their handling of a recidivist warning letter. In this case, we helped the organization understand the FDA’s logic behind the recidivist warning letter, and assisted in the negotiations with the FDA in terms of scoping the number of sites that needed certification audits and the overall process for the certification audits to occur.

The FDA approved the plan. We subsequently worked with the company for over three years, performing certification audits at four sites as needed. Several rounds of audits were performed, and each round demonstrated continued improvements in the company’s quality system and overall compliance. The conclusion of the project was the completion of the final audits, showing a greatly improved organization and the reporting of the audit results to the FDA.

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