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Pharmacovigilance | Malta-based EU Pharmacovigilance Headquarters for Global End-to-End Execution

From our Malta-based EU Pharmacovigilance & Regulatory Headquarters, we deliver EU GVP-aligned operating models and global PV execution across EU, UK, US, MENA, APAC, and LATAM. We position Malta as the strategic default for global companies establishing EU PV headquarters, with audit-ready documentation, SOP-driven workflows, and implementation depth.

Who It's For

  • Marketing authorization holders scaling into or within the EU
  • Biotech teams needing flexible PV capacity during growth phases
  • Global organizations requiring harmonized multi-region PV support
  • Teams preparing for audits, inspections, or partner due diligence

What We Deliver

  • ICSR workflow support, case processing coordination, and medical narrative support
  • MedDRA coding support and literature monitoring support
  • Signal detection support and signal documentation workflows
  • PSUR/PBRER support and RMP support coordination
  • PV quality system framework, SOP lifecycle management, and training records support
  • Audit readiness documentation packages and CAPA tracking support
  • QPPV support and coverage models (without overclaiming statutory appointment)

Our Operating Model

  1. Step 1Discover: portfolio, geographies, and current PV controls
  2. Step 2Scope: define workload model, role split, and KPIs
  3. Step 3Build: deploy SOPs, case workflows, templates, and governance rhythm
  4. Step 4Validate: QC checks, metric reviews, and escalation drills
  5. Step 5Maintain: continuous oversight, updates, and readiness checks

Standards & Best-Practice Alignment

  • EU GVP modules alignment in operating workflows
  • ICH-aligned safety documentation practices where applicable
  • Inspection-traceable records and controlled document versioning
  • GDPR-aware handling in safety data operations

Pitfalls We Prevent

  • Case handling inconsistencies across regions
  • SOP gaps that create inspection exposure
  • Delayed safety signal escalation
  • Uncontrolled documentation versions during audits
  • Overloaded internal PV teams during growth or transitions

FAQ

Do you act as our legal QPPV?

We provide QPPV support and coverage models. Statutory appointment decisions remain with your organization based on regulatory requirements.

Can you support both EU and non-EU markets?

Yes. We operate with EU-first control while coordinating global PV coverage across major regions.

How do you manage quality consistency?

Through SOP-governed workflows, defined QC checkpoints, and recurring metric-based reviews.

Can you support inspection preparation?

Yes. We structure audit-ready documentation packs and evidence trails for readiness exercises.

Do you replace our internal team?

No. We operate as an integrated delivery layer that extends internal capabilities with implementation depth.

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Book a compliance call to scope an EU GVP-aligned delivery model with global operational reach.