Amarex Clinical Research offers a full suite of Post-Market and Pharmacovigilance services for pharmaceutical, biologic, and medical device companies. Our services are grounded in ISO 14971, the global gold standard for risk management, and are designed to help you:

• Reduce internal workload and headcount
• Accelerate complaint resolution
• Avoid costly regulatory actions
• Improve ROI through scalable, expert-driven support

Our Services Include:

Medical & Risk Assessment Services

• Narrative writing and assessments for drugs, biologics, devices, and combination products
• MDR reportability evaluations
• Seriousness, expectedness, and relatedness assessments

Risk Management & Hazard Analysis

• ISO 14971-aligned risk assessments
• Health Hazard Assessments (HHAs)
• Hazard identification and evaluation

Medical Writing & Justifications

• Complaint adjudications and rationale development
• Device investigation and recall evaluations

Training & Expertise

• Internal and client-facing training on ISO 14971 and risk management best practices

Why Amarex?

• Cost Savings – Reduce reliance on internal FTEs or consultants
• Regulatory Confidence – Stay compliant with ISO 14971 and global standards
• Scalability – On-demand support during audits, recalls, or complaint spikes
• Speed to Resolution – Faster assessments by experienced professionals
• Strategic Focus – Free up your team to focus on innovation