Quality: the cornerstone of the pharmacovigilance system
What it is about
In the pharmaceutical sector, Pharmacovigilance is a central element for safeguarding public health, protecting patients, and ensuring the sustainability of products on the market.
A well-structured and robust Pharmacovigilance Quality System ensures traceable processes, reliable data, and effective risk management, guaranteeing full compliance with current regulations and Good Pharmacovigilance Practices (GVP).
Managing quality in Pharmacovigilance proactively means preventing critical issues, improving system performance, and approaching audits and inspections with confidence and awareness.
Our strengths
➕ Strategic approach: we support companies in the interpretation and application of Pharmacovigilance regulations and guidelines (EU Legislation, GVP, ICH guidelines), with the aim of ensuring the implementation of an appropriate and effective Quality System and guaranteeing compliance with the obligations required of Marketing Authorization Holders (MAHs).
➕ Technical and cross-functional expertise: we have professionals experienced in the management of Pharmacovigilance Quality Systems, Quality Assurance and Audits (training, SOP development, vendor qualification, KPI identification and management, audit program definition and execution, deviation management and CAPAs), as well as continuous improvement processes (system reviews, compliance assessments and implementation of remediation plans), capable of integrating quality into daily operational activities.
➕ Qualified, timely, flexible and tailored service: we operate as an extension of your team, supporting you through every phase – from initial gap assessments to the identification of training needs and SOP development, from risk analysis to the design of strategic and tactical audit programs – with an approach focused on your organization, product portfolio and business needs.
➕ Inspection Readiness: through our strategy, expertise and services, we support companies in preparing for Pharmacovigilance Inspections and managing all required follow-up activities (from finding assessment to root-cause analysis and CAPA Plan management, mock inspections and PSMF review).
How we can help you
We can provide you with a team of experts or Auditors, or directly assume the role of Quality Assurance Manager for Pharmacovigilance
What we can do
✅ Quality
- Definition, review and implementation of quality systems (Quality Manual or Quality Plans, SOPs, work instructions, compliance checks, risk assessment and KPIs)
- System, Process and Product Audits, vendor audits, compliance assessments and mock inspections
- Non-conformity management, CAPAs, continuous improvement programs
- Support in the preparation and management of audits and regulatory inspections
- Monitoring of compliance checks and KPIs, reporting and trend analysis
- Definition and management of Pharmacovigilance Agreements and service contracts
- Traceability, change management, management of vendors and Business Partners
- Workflow optimization and process risk reduction
✅ Training and quality culture in Pharmacovigilance:
- Design and delivery of training programs for company personnel
- Preparation of internal and external communications dedicated to corporate quality (quality reports, newsletters, board communications)
- Regulatory Intelligence
- Support in promoting the company’s “quality culture”, making Quality in Pharmacovigilance an integral part of the Business strategy
Products covered
✅ Development and authorized medicinal products
Who it is for
✅ Italian and international companies
✅ Companies holding Marketing Authorizations (MAHs) in Italy and abroad