IntuVigilance

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Drug Safety & Pharmacovigilance Capabilities

End-to-end pharmacovigilance services for compliant, scalable, inspection-ready operations
We support Marketing Authorisation Holders, Commercial and Academic Clinical Trial Sponsors, Biotech companies and CROs across every stage of the product lifecycle – combining experienced teams, robust processes, and regulatory-aligned workflows.
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Local QPPV services
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Overview

Expert teams. Robust processes. Regulatory-compliant delivery.

Case Processing

Cost-efficient, accurate case handling with compliant reporting and full audit trail visibility.

Signal Management

Robust signal detection, assessment, and documentation to support defensible safety decisions.

QPPV / LSO Support

EU/EEA, Eurasia, CIS, Africa, APAC, Europe, Central and South America, Middle East, North America, Canada.

PV System Support

Local and Global literature screening, EU PSMF and local PSMF preparation and maintenance, RMPs, PSURs, Aggregate Reports, Special local reports in an inspection-ready state.

Argus Case Processing Support & Reporting

End-to-end case processing, from intake and validation through to coding, medical review, quality control and expedited submission.

Value delivered: fast, accurate, compliant case handling that reduces operational burden and inspection risk.

  • Case intake, triage, and validation
  • MedDRA and WHO-DD coding
  • Global ICSR submissions
  • Country-specific timelines and follow-up
  • Narrative writing and medical review
  • Multi-layer quality control
  • E2B(R3) compliant Argus safety database

Signal Management

Early identification, assessment, and documentation of potential safety risks - combining structured processes, scientific review and regulatory awareness.

Value delivered: early identification of emerging risks and well-supported signal decisions.

  • Signal detection in R&D and post-authorisation
  • Assessment and documentation
  • Recommendations and tracking
  • Literature and regulatory intelligence inputs
  • Signal validation and prioritisation
  • Safety review meetings
  • Disproportionality analysis

Periodic & Aggregate Reporting

High-quality reports prepared by experienced pharmacovigilance professionals and safety physicians, combining strong medical writing with data consistency checks.

Value delivered: Audit-ready Regulatory-Grade reporting built to satisfy standard EU/EEA frameworks as well as unique, localized periodic requirements.
  • PSUR / PBRER
  • PADER / PAER
  • Medical writing and clinical review
  • Regulatory-aligned templates
  • DSUR
  • Line listings and summary tabulations
  • QC and consistency checks

Literature Monitoring

Reliable, indexed as well as non-indexed journal lists that cover global territories; screening, review and assessment for ICSRs and safety-relevant information; Weekly MOH website monitoring to check for safety alerts, recalls, class effects, regulatory updates.

Value delivered: reliable identification of literature cases and safety signals.

  • Weekly or monthly searches
  • Local language screening
  • ICSR reporting support
  • Global and local coverage
  • Case identification and extraction
  • Documentation and quality control

EU/EEA and Local PSMF Management and Support.

A complete, inspection-ready PSMF that accurately reflects the pharmacovigilance system in operation - core documents, annexes, oversight and readiness tracking.

Value delivered: a complete, inspection-ready PSMF that accurately reflects your PV system.

  • EU PSMF and local PSSFs - creation and updates
  • QPPV oversight support
  • Inspection readiness support
  • Annex management
  • KPI and compliance tracking

Strategic Audits & Inspections

We plan and execute partner/vendor audits and provide comprehensive support for regulatory inspections (MHRA, ANSM, ISP, etc.), using a risk-based approach aligned to the latest GVP modules.

Value delivered: an inspection-ready PV system, backed by quarterly oversight meetings with global partners.

  • Partner and vendor audit planning & execution
  • Risk-based approach aligned to GVP modules
  • Regulatory inspection support
  • Quarterly global partner oversight meetings

Training & QMS

Training aligned with our Quality Management System - pharmacovigilance awareness training for sales teams and non-PV staff, delivered through our PV Academy.

Value delivered: an inspection-ready PV system, backed by quarterly oversight meetings with global partners.

  • Pre-designed and customisable training modules
  • Gap analyses and process development
  • PV Academy mentorship
  • 350+ SOPs across PV, QA, HR and IT
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Why Clients Choose Us

Technical quality, medical oversight, scalable delivery
Deep-seated PV expertise, technical and operational excellence, scalable delivery pathways. We provide a dependable extension of your safety function, with workflows built for compliance and transparency.

Compliance Metrics

Built into every deliverable, from expedited reporting, periodic reporting, PVAs, STAs and training.

Oversight & Multi-layer QC

Every output reviewed for accuracy, consistency and regulatory alignment.

Scalable capacity

Built for growth and expansion of deliverables.

Transparent SLAs & KPIs

Clear, measurable performance metrics that are shared in Quality Reports.

Audit-ready documentation

Every process and output is built to withstand regulatory scrutiny.

Seamless integration

We fit into your existing processes, not the other way around - delivering a seamless, glove-like fit for your operations.

Talk to IntuVigilance about building a stronger, more scalable PV operation.
Fast, compliant, scalable, and inspection-ready – so you can focus on strategy, not operational burden.
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