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Post-Market Surveillance
Strengthening Safety, Compliance, and Control Across the Product Lifecycle
Post-market surveillance is critical to protecting patients, maintaining compliance, and sustaining product performance after launch. We help life sciences organizations design and operate inspection-ready surveillance programs that support ongoing safety monitoring, regulatory reporting, product improvements, and risk management across the product lifecycle.
Our Post-Market Surveillance Solutions
We partner with organizations to design, operate, and strengthen post-market surveillance models that integrate processes, systems, and governance across global product portfolios. Our approach focuses on best practices, consistency, traceability, and regulatory alignment to support both day-to-day operations and long-term compliance.
Post-Market Surveillance Strategy and Program Design
We help define surveillance strategies aligned to product risk, regulatory requirements, and organizational maturity. Programs are designed to be scalable, auditable, and adaptable as regulations and portfolios evolve.
Complaint Handling and Case Management
We support structured complaint intake, investigation, documentation, and closure processes that meet global regulatory expectations. This ensures timely handling, clear traceability, and defensible decision-making while streamlining and instituting best practices.
Vigilance and Regulatory Reporting
We support vigilance activities including adverse event assessment, reportability decisions, and submissions. Our focus is on accuracy, timeliness, and consistency internationally.
Signal Detection and Risk Management
We help organizations identify, assess, and escalate safety signals through integrated surveillance and risk management processes. This supports proactive risk mitigation and informed regulatory engagement.
CAPA and Quality Integration
We align post-market findings with CAPA and quality management processes to ensure issues are addressed systematically. This creates a closed-loop approach with feedback that supports continuous improvement and compliance.
Systems and Data Enablement
We support the effective use and optimization of post-market systems and data sources, providing metrics that enable improved visibility, traceability, and reporting across surveillance activities.
Post-Market Surveillance Capabilities
We help organizations strengthen post-market performance through disciplined operating models, integrated quality processes, and consistent execution.
Regulatory and Inspection Readiness
Processes and documentation practices designed to support audits, inspections, and regulatory inquiries.
Operational Control and Traceability
Clear workflows, governance, and reporting that support oversight, accountability, and defensible decision-making.
Integrated Quality and Risk Management
Alignment across surveillance, CAPA, design risks, and quality systems to ensure issues are identified, assessed, and resolved effectively.
Scalable Global Delivery Models
Support that adapts to product complexity, geographic scope, and changing regulatory requirements.
Why Oxford?
Organizations choose us because we understand the operational and regulatory realities of post-market surveillance and deliver practical solutions that improve products and strengthen compliance while achieving business outcomes.
Post-Market and Quality Expertise
We are experienced in supporting surveillance, vigilance, and quality programs across global life sciences organizations.
Structured Operating Models
Clear, repeatable frameworks and best practices that support consistency, traceability, and regulatory confidence.
Regulatory and Quality Alignment
Hands-on understanding of how post-market surveillance integrates with CAPA, risk management, and quality systems.
Execution in Complex Environments
We work effectively within high-volume, data-driven environments, helping teams maintain control, coordination, and timely reporting across surveillance activities.
Flexible Engagement Models
Support delivered through staffing, co-managed, or full delivery models with the core competencies and skills aligned to your needs.
Focus on Control and Sustainability
An emphasis on building surveillance programs that are robust, inspection-ready, and sustainable.
Strengthen Post-Market Surveillance with Confidence
Effective post-market surveillance requires more than compliance. It requires clear processes, strong governance, and reliable execution across the product lifecycle. We help life sciences organizations strengthen their post-market surveillance programs so safety risks are managed, obligations are met, and trust is maintained long after launch.
Ready to strengthen your post-market surveillance program? Connect with our team to discuss your needs.
Leadership Team
Cristel Saenen
Solutions Executive, Life Sciences
Cristel partners with life sciences organizations to support post-market surveillance and ongoing compliance initiatives across regulated environments. She works closely with clients to align specialized expertise with critical priorities related to product quality, patient safety, reporting, and regulatory oversight.
Known for her collaborative and client-focused approach, she helps organizations navigate evolving post-market requirements while supporting operational efficiency and long-term compliance. Her experience across pharmaceutical, biotechnology, and medical device sectors enables her to deliver tailored consulting solutions aligned to complex regulatory and quality demands.
Terrell Iglehart
Solution Leader, Life Sciences
Terrell supports pharmaceutical, biotechnology, and medical device organizations with post-market surveillance and quality initiatives focused on patient safety, compliance, and operational improvement. He specializes in helping organizations strengthen governance, manage risk, and navigate complex regulatory requirements fostering process improvements and sustainability.
With extensive experience leading remediation programs, CAPA initiatives, and quality system transformation efforts, he helps organizations improve oversight, strengthen accountability, and adapt to evolving regulatory expectations. His collaborative and practical approach enables clients to build sustainable and compliant processes that fosters both product improvements and operational performance.
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