Inspection readiness

Pharmacovigilance Inspection Readiness

Pharmacovigilance Inspection Readiness

Inspection Readiness en Pharmacovigilance

Prepare Your Organization Effectively for ANSM and EMA Inspections

In an increasingly demanding regulatory environment, pharmacovigilance inspections represent a critical challenge for pharmaceutical companies, Marketing Authorization Holders (MAHs), and Life Sciences organizations.

Health authorities, particularly the ANSM and the EMA, assess:

– the robustness of pharmacovigilance systems

– the quality of safety data

– the control of regulatory processes

– the organization’s ability to demonstrate compliance with Good Pharmacovigilance Practices (GVP)

An effective Inspection Readiness strategy enables organizations to anticipate regulatory expectations, secure critical activities, and reduce regulatory risk exposure.

Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the preparation, assessment, and reinforcement of their pharmacovigilance systems ahead of inspections.

Our objective: to help you approach inspections with a robust, compliant, and defensible pharmacovigilance system.

Anticipate Risks Before Inspections


Pharmacovigilance inspections go far beyond document reviews. Authorities assess:


  • overall PV governance
  • operational oversight of activities
  • traceability of decisions and processes
  • the ability of teams to justify compliance practices



Atessia Vigilances implements a structured approach enabling organizations to:


  • identify compliance gaps
  • assess critical processes
  • strengthen documentation traceability
  • prepare teams for interactions with inspectors
  • secure sensitive regulatory activities



A proactive preparation model designed to sustainably strengthen your compliance level.

Evaluate the Robustness of Your Pharmacovigilance System


Our teams conduct in-depth assessments of pharmacovigilance systems and activities in order to identify risk areas and improvement opportunities.


Our services include:


  • review of PV Quality Systems
  • GVP compliance assessments
  • evaluation of critical processes
  • review of SOPs and quality documentation
  • assessment of outsourced activities
  • verification of EU-QPPV and Local PV Responsible Person responsibilities
  • review of EudraVigilance and regulatory reporting activities



Clear visibility of your compliance status and priority remediation actions.

Prepare Your Teams for Health Authority Expectations


Pharmacovigilance inspections involve both operational and strategic interactions with health authorities.


Atessia Vigilances conducts mock inspections designed to:


  • simulate ANSM and EMA inspections
  • assess team responsiveness
  • identify organizational weaknesses
  • prepare teams for inspector interviews
  • test the availability and consistency of critical documentation



Realistic simulations designed to strengthen team confidence and inspection preparedness.

Strengthen Traceability and Process Compliance


Documentation quality is a central focus during pharmacovigilance inspections.


Our experts support:


  • PSMF reviews
  • analysis of PV SOPs and workflows
  • review of case management activities
  • compliance assessment of regulatory reports
  • traceability of Signal Management activities
  • documentation review of MLM and EudraVigilance activities



Documented, consistent, and auditable processes aligned with health authority expectations.

Sustainably Strengthen Regulatory Compliance


Identification of compliance gaps must be supported by effective and risk-based remediation plans.


Atessia Vigilances supports organizations with:


  • root cause analysis
  • CAPA definition and implementation
  • prioritization of critical remediation actions
  • monitoring of remediation plans
  • oversight of corrective and preventive measures



A pragmatic approach designed to sustainably strengthen control over PV activities.

Inspection Readiness for Outsourced Activities


Health authorities pay particular attention to oversight of outsourced pharmacovigilance activities.


We support organizations with:


  • assessment of vendors and distributors
  • review of Pharmacovigilance Agreements (PVAs)
  • audits of outsourced activities
  • verification of regulatory responsibilities
  • quality oversight of business partners



Strengthened governance designed to reduce risks associated with outsourcing models.

Reinforce Regulatory Expertise Across Your Organization


Team preparation is essential to ensure successful pharmacovigilance inspections.


Atessia Vigilances provides targeted training programs for:


  • pharmacovigilance teams
  • quality functions
  • regulatory affairs departments
  • medical information teams
  • EU-QPPVs and French Local PV Responsible Persons
  • Responsible Pharmacists



Our programs cover:


  • EMA and ANSM expectations
  • Good Pharmacovigilance Practices (GVP)
  • inspection behaviors and communication
  • management of inspector questions
  • documentation best practices



Operational training programs designed to effectively prepare teams for inspections.

Systems Designed to Be Compliant, Robust, and Auditable


Our Inspection Readiness methodologies are based on:


  • EMA and ANSM requirements
  • Good Pharmacovigilance Practices (GVP)
  • risk-based approaches
  • pragmatic and operational methodologies



We ensure:


  • structured assessments
  • actionable recommendations
  • sustainable process improvements
  • protection of critical activities



A global approach designed to reduce regulatory risk and strengthen PV governance.

Why Choose Atessia Vigilances?

Experienced consultants specialized in inspections, audits, and PV compliance.

Compliance with EMA, ANSM, and GVP expectations.

Recommendations tailored to operational realities and organizational constraints.

Methodologies specifically designed to meet health authority expectations.

Targeted support, focused remediation projects, or comprehensive Inspection Readiness programs.

What You Gain by Working with Us ?

– Reduced regulatory risk

– Enhanced preparedness for EMA and ANSM inspections

– Strengthened pharmacovigilance systems

– Secured critical and outsourced activities

– Increased expertise of key functions and operational teams

Besoin d’un partenaire expert en Inspection Readiness ?

Atessia Vigilances vous accompagne dans l’évaluation, la préparation et la sécurisation de vos systèmes de pharmacovigilance afin d’anticiper efficacement les inspections réglementaires.

Contactez-nous