Post-Marketing Pharmacovigilance
End-to-End Pharmacovigilance. Trusted Compliance. Global Readiness.
BioEthica offers scalable pharmacovigilance solutions to support marketed products. We prioritize patient safety and regulatory compliance through tailored expert pharmacovigilance services. Our team delivers end-to-end post-marketing solutions to ensure the safety of your products and stakeholder confidence.
From adverse event case processing to aggregate report submissions, our US-based, medically trained team ensures compliance with FDA, EMA, and ICH standards.
Pharmacovigilance Services for Every Stage of Your Product’s Lifecycle
Adverse Event Case Management
Complete handling of clinical and post-marketing safety data. We ensure accurate triage, data entry, medical coding, and timely follow-up so no case falls through the cracks.
Expedited & Regulatory Reporting
Rapid submission of SUSARs, SAEs, and serious ADRs to meet global regulatory timelines.
Medical Review by Licensed Experts
US-licensed physicians and pharmacists evaluate case seriousness, causality, and expectedness—bringing clinical nuance to safety decision-making.
MedDRA Coding & Data Quality Control
Precision MedDRA coding ensures consistency in case narratives and data outputs, enabling reliable signal detection and regulatory compliance.
Aggregate Safety Report Development
DSURs, PSURs, PBRERs, and PADERS - authored, quality-checked, and delivered on time to meet regulatory requirements.
ICSR & Safety Database Submissions
We handle secure, validated electronic submission of Individual Case Safety Reports (ICSRs) into FAERS; we are global systems capable.
Global Literature Monitoring
Routine surveillance of scientific publications to capture emerging safety information - fully compliant with EMA GVP Module VI and FDA expectations.
Signal Detection & Safety Surveillance
Proactive review of safety trends across your portfolio, with formal signal detection, assessment, and documentation to support risk-benefit decisions.
Risk Management Planning
Development and lifecycle maintenance of Risk Management Plans (RMPs) tailored to product profiles and evolving risks.
Global Compliance & Audit Readiness
Our systems and SOPs align with FDA, EMA, and ICH E2E-E2F guidelines - keeping clients inspection-ready at all times.
Bridging US and EU Pharmacovigilance Requirements for Seamless Regulatory Success
MA sponsors and MAHs often partner with US pharmacovigilance teams to strengthen FDA readiness while maintaining global compliance. BioEthica provides clients with:
- A deep understanding of both US and EU PV regulatory landscapes
- Seamless coordination of global and local reporting requirements
- Native English-speaking medical professionals handling your cases and reports
- Full alignment with EMA GVP Modules and FDA PV regulations
BioEthica makes global safety compliance feel local.
With advanced safety systems and a dedicated team backed by agency experience, we streamline pharmacovigilance processes to deliver reliable, high-quality results. When you’re navigating post-marketing obligations, BioEthica is your trusted partner for patient safety and regulatory success. Contact us today to discuss how we can support your pharmacovigilance needs.