Risk Mitigation Strategy

In today’s global competitive market, maintaining market share is critical in achieving greater scale in operations and improved profitability, plus providing the ability to introduce new products effectively through multiple markets, segments, and channels. The problem is that most companies do not properly manage their quality and compliance initiatives due to extra focus on other areas of the business. Thus, noncompliance can surface and bring about unwarranted expenses and issues leading to potential recalls, adverse events, and more importantly, potential loss of market share.

QualityHub has a solid record of helping companies mitigate regulatory enforcement and respond to regulatory emergencies in order to avoid costly product approval delays, recalls, loss of brand integrity, and negative impacts to shareholder value. We provide quality and compliance experts who concentrate on assisting you in developing and maintaining a culture of compliance and continuous improvement through the use of an integrated series of risk mitigation services. Our team will develop a strategy that aligns to your business needs and at the same time addresses your compliance risks. Plus, we can assist you with navigating the “regulatory waters” due to our close relationships with the regulatory agencies. Our risk mitigation and prevention strategies are designed around the concept that a good offense is better than a good defense.

QualityHub can assist you with the following services and more:

  • Conduct proactive audits/risk assessments to evaluate compliance and regulatory risks
  • Development of continuous improvement and sustainability strategies
  • Assist with the preparation and management of FDA and Regulatory body inspections, including product pre-approval inspections
  • Provide executive coaching and assessments
  • Assist with FDA and Regulatory body communications and/or inspections, plus any needed post-inspection communication and correspondence
  • Perform FDA Inspection Readiness Training
  • Perform Mock-FDA training audits
  • Evaluation and simplification of quality and compliance programs
  • Perform due-diligence assessments
  • Risk Management development and implementation

 

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