Responding to FDA Enforcement

As the FDA and other regulatory agencies increase their surveillance and enforcement actions, life science companies are turning to IQVIA. Our team of industry experts, including some who have worked at the FDA, help clients respond with distinct and effective strategies to restore client credibility with the FDA — as well as strengthen their quality processes with cost-effective approaches. 

Our experts can help your teams: 

  • Provide strategic consultation on quality Perform mock FDA inspections and Develop and implement systems and GMP/QSR compliance FDA preparedness training quality systems
  • Conduct GMP/QSR assessments Develop and execute Create and implement and training validation programs corrective action plans 
  • Undertake internal and Investigate suspected fraud Provide strategic direction for effectively supplier audits and scientific misconduct managing organizational changes to quality systems, processes and cultural transitions 

Our pragmatic approach reflects years of real-world experience implementing projects with clients. We customize our project plans based on client culture and project needs. 

Contact us and let’s put our expertise to work for you.