Product Safety and Drug Development
Regulatory compliance and product defense
When golf champions win, it’s often in the spotlight, watched carefully by competitors, fans, and television audiences potentially totaling millions of people. The stress is extraordinary. Likewise, pharmaceutical, biotech, and medical device companies are closely scrutinized by regulators, investors, the medical community, patients, and the public. These businesses have the potential to change lives, but do so under extraordinary pressure.
Performance under pressure
Deloitte works with life sciences companies to develop practical, executable strategies for addressing critical issues such as pharmacovigilance (PV) execution and drug safety compliance, document management, adverse events processing, and product safety monitoring. Our practitioners have significant experience across a broad cross-section of life sciences organizations addressing PV. Deloitte is recognized as world class and a thought leader in the life sciences industry.
Product Safety and Drug Development services
- Product safety and drug development. We specialize in promoting operating model growth for drug safety by defining a strategic plan and corresponding road map that leverage global regulatory intelligence.
- Process design. We help transform the drug safety process through insightful analysis, organization and process design, and key performance metrics. We also help with deployment of standard operating procedures (SOP), work instruction (WI) development, training, organizational change management, and risk management.
- Business intelligence. We help incorporate analytics, visualization, and reporting to address compliance, measure performance using process metrics, and institute continuous improvement. We leverage hands-on experience with signal detection, data warehouses, and datamarts for consolidation of safety data and training.
- Implementation services. Our services include software development life cycle (SDLC) support for system implementations and upgrades; configuration implementation; E2B implementation and agency consultation; and data migration, vendor management, and integration design.
Potential bottom-line benefits
- Regulatory compliance and effective product defense
- Improvements in operational efficiency and risk management
- Resource utilization improvements and scalable processes
- Improved use of performance measurements
- Informed decision making through improved access to business intelligence data and analytics
Scrutinized closely across the life cycle of a drug or device, life sciences companies strive for performance under extraordinary pressure.