DEA / FDA and Regulatory Compliance
Robust compliance programs to reduce your current and future exposure
Whether it’s the regulations of the DEA, the FDA’s Prescription Drug Marketing Act (PDMA), Part 11 regulations or the state regulations that are keeping you up at night, IQVIA has the solutions to help you stay compliant. Our teams of compliance experts, comprised of former state and federal regulatory officials and industry compliance leaders, can help you build programs to reduce your current and future exposure, while keeping your organization running efficiently.
In the face of increasing government enforcement, it’s more important than ever for pharmaceutical manufacturers, distributors, hospitals, and pharmacies to be fully compliant. To address issues related to regulatory compliance we offer:
- On-site assessments, reviews, and mock inspections
- Set up of operations, records and reports
- SOP development/reviews
- Due-diligence reviews
- Customized regulatory training
- Statistically derived Significant Loss Threshold (SLT) establishment
- Registration/approval process assistance
- DEA Suspicious order monitoring and customer due-diligence assistance
- Assistance obtaining DEA registrations
And, since healthcare regulations consistently change, we provide services to help track and interpret these changes. eRegMonitor™ is the most complete, centralized repository of summarized, on-demand state and federal regulatory information relevant to the life sciences industry. This web-based dashboard provides 24/7 web access to critical legislative and regulatory information in 13+ key research areas. Each database is searchable and includes proactive email notifications when laws change.
Contact us and let’s put our regulatory expertise and experience to work for you.
Podcasts discussing the latest initiatives from the Drug Enforcement Administration are now available.
- Podcast 1: DEA Suspicious Order Monitoring
- Podcast 2: How Legislators and the DEA Are Addressing the Opioid Crisis in the U.S.