Regulatory Strategy: Consent Decrees

In the midst of chaos, there is also opportunity.

A Consent Decree signifies a pivotal point in any company’s lifecycle. It has the power to impact the company financially, incur lost revenue, and potentially alter the public’s perception of the company, brand and products. In some cases, companies have failed to recover from this situation. With the support of Senior Leadership and proper guidance from a highly qualified group such as QualityHub, the solution is achievable.
 
QualityHub has been through the process of supporting clients in Consent Decrees. We understand what it takes to be successful and restore your credibility, competitive advantage and revenue. If you find yourself in this indefensible situation, we have the knowledge, skills and abilities — and the experienced team — to partner with you during your journey to success and compliance.
 
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Consent Decree Project Examples

Project 1 (Client A) – Served as 3rd Party Expert (18 month project)

  • Verification Audits (9 Systems)
  • In-Depth “Product Reviews” of DHF and related documents based on Consent Decree requirements (Numerous “product issues”)
  • Met with FDA District Office on Strategy
  • Worked with the Company’s FDA Attorneys

 


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