Fostering meaningful growth in Life Science
Regulatory Affairs • Quality Assurance • Pharmacovigilance Medical Communication • Market Access • Public Affairs Compliance • Project Management

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.

PV Mandates

EU QPPV & UK QPPV
EudraVigilance Responsible Person
Swiss PV Responsible Person
EU local QPPV services

PV Systems

PSMF (EU & UK) creation and update
PV specific SOPs
Gap assessment and inspection readiness
Offering operational PV support withing client PV system

PV Compliance

GVP & GCP Audits
PV Mock inspections
PV Agreements
PV Regulatory intelligence

PV Operations

Signal management
RMP and Aggregate reports (PBERE, PSUR & DSUR)
XEVMPD activities (AMP/DMP entry and maintenance)
Global & local literature search and strategy
Luminance Health GmbH Zwingerstrasse 10 4053 Basel Switzerland
©
2025
Luminance Health GmbH
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