Pharmacovigilance
At Luminance Health, we provide comprehensive Pharmacovigilance services tailored to the unique needs of pharmaceutical and medtech companies. With deep expertise in Swiss, EU, and UK regulatory landscapes, we support organizations of all sizes - from emerging innovators to global market leaders - ensuring the highest standards of safety and compliance.
Strategic PV Leadership
We offer expert PV mandate services, seamlessly integrating into your operations to fulfill critical regulatory roles. Our specialists act as key safety representatives across multiple jurisdictions, helping clients navigate complex national and international requirements with confidence.
Building Resilient PV Systems
We design, implement, and maintain robust PV systems that meet regulatory demands while supporting operational efficiency. From system setup to documentation and process development, we ensure your safety functions are inspection-ready and aligned with best practices.
Compliance and Inspection Readiness
Staying compliant in an evolving regulatory environment requires ongoing vigilance. Our services include audits, mock inspections, and regulatory intelligence to ensure your PV activities meet the latest requirements and are ready for health authority evaluations.
Data-Driven PV Operations and Reporting
We provide hands-on operational support to enhance clients' PV functions by seamlessly working within their existing safety systems and global safety databases. Our experienced professionals handle critical activities such as the preparation of risk management plans and aggregate safety reports, enabling clients to meet essential regulatory requirements efficiently.
A key component of our support includes signal management, where we help clients identify, validate, and assess potential safety concerns to prioritize actions and maintain the highest level of patient safety. Our data-driven approach ensures that decisions are backed by thorough analysis, supporting a strong and proactive risk-benefit evaluation throughout the product lifecycle.
Luminance Health is your trusted partner for premium pharmacovigilance solutions, helping you maintain compliance, reduce risk, and prioritize patient safety at every stage of your product lifecycle.