KPMG Risk Evaluation and Mitigation Strategy (REMS) Compliance Audit Services
Navigate REMS Compliance with confidence, efficiency, and insight
KPMG Life Sciences professionals work closely with drug manufacturers operating under a Risk Evaluation and Mitigation Strategy (REMS) program to help them understand and address their compliance and auditing needs.
KPMG Experience with REMS
Our in-depth knowledge and experience with REMS programs of all sizes uniquely position us to assist your organization in assessing compliance with REMS requirements and meeting required audit and reporting obligations. As a REMS audit provider, KPMG understands that successful audits go beyond mere execution. We emphasize:
- Clear communication to meet timelines and drive accountability.
- Enhanced stakeholder experience with focused audit scopes to minimize burden.
- Real-time insights for continuous improvement.
- Timely responses to regulatory requests.
- Seamlessly scaling programs to adapt to changing needs.
How KPMG can help
Our team provides specialized support for a variety of compliance, R&D, and commercial functions within the Life Sciences industry. Our services include:
- REMS Stakeholder Audits
- REMS Program Vendor Audits
- Project Management Framework
- FDA Inspection and Inquiry Support
- Assessment Report Support
- Trend Analysis & Program Insights
- Continuous Improvement Identification
KPMG Accelerators: KPMG Concert
KPMG leverages KPMG Concert, a proprietary, validated digital platform with AI-enabled workflows to manage REMS audits from notification to closure. Concert centralizes communication, documentation, and data capture, delivery of accessible, real-time dashboards. This enables timely, informed decisions and updates while scaling seamlessly with fluctuations in audit volume.
Ready to strengthen your REMS program?
Connect with us today to discuss how our tailored audit solutions and digital accelerators can support your organization's goals and regulatory requirements.
Dive into our thinking:
Get a deeper understanding of our approach to REMS compliance and how our tailored solutions can support your organization's goals.
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