Global Oversight, Local Expertise, Continuous Compliance
Ensuring a compliant and effective pharmacovigilance system requires both centralized oversight and strong local representation. We provide Qualified Person for Pharmacovigilance (QPPV) services supported by an extensive network of local safety professionals, enabling seamless compliance across global and national regulatory environments.
Our model integrates strategic oversight with operational execution, ensuring that your pharmacovigilance system remains:
Our QPPVs assume full responsibility for the establishment, maintenance, and continuous oversight of your pharmacovigilance system.
Acting as the primary point of contact with regulatory authorities, they ensure that all safety activities are conducted in accordance with global regulations and Good Pharmacovigilance Practices (GVP).
Oversight of the entire pharmacovigilance system and its performance
Continuous benefit–risk evaluation throughout the product lifecycle
Regulatory interface with competent authorities and inspection bodies
24/7 availability for safety-related matters and escalation
We provide end-to-end PSMF services to ensure your system documentation is accurate, up-to-date, and inspection-ready at all times.
Authoring, maintenance, and ongoing updates of the PSMF
Management of pharmacovigilance agreements (SDEAs / PVAs)
Alignment with regulatory requirements across regions
Continuous quality review and audit readiness
We provide a robust network of qualified local pharmacovigilance representatives to meet country-specific regulatory requirements.
Our Local Experts
Ensure compliance with local pharmacovigilance legislation
Support adverse event reporting and local safety surveillance
Provide language, regulatory, and cultural expertise
Maintain readiness for inspections and authority interactions
These roles, whether defined as Local Person for PV (LPPV), Local Safety Officer (LSO), or Local Contact Person (LCPPV), Act as the local extension of your global PV system.
With a wide geographical reach, Baupharma extends its expertise and services to clients and partners across the globe. Our global presence, supported by four strategic offices in different regions, enables us to deliver exceptional solutions that meet the unique requirements of each market.
We operate a coordinated framework where global QPPV oversight is seamlessly connected with local PV activities. This ensures consistency, visibility, and control across all markets.
This model enhances both compliance and operational efficiency while reducing regulatory risk.
Centralized oversight with structured local coordination
Harmonized processes across regions and affiliates
Clear governance and communication pathways
Consolidated safety intelligence from global and local sources to support signal management
To strengthen your pharmacovigilance system,
Regulatory intelligence and change impact assessment
PV system setup and continuous improvement
SOP and quality system development
Audit and inspection preparation and support
Training programs tailored to global and local requirements
Complete QPPV and local PV coverage
Integration with your internal PV teams
Specific services such as PSMF maintenance or local representation
Global network with strong local regulatory presence
Experienced QPPVs and country-specific PV professionals
Inspection-ready systems and proactive compliance management
Integrated PV, regulatory, and quality expertise
Flexible, client-centric delivery models
Providing a structured, reliable, and proactive pharmacovigilance framework that supports patient safety and business continuity across all markets.
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Proactive Safety Intelligence from Global Scientific Sources
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