Pharmacovigilance

At Lariox Pharma, patient safety is paramount. We develop and implement comprehensive pharmacovigilance (PV) strategies for all stages of your product's lifecycle.

• Early Integration: We begin working with you during the regulatory stages, providing safety specifications, Pharmacovigilance System Master Files (PSMFs), and Risk Management Plans (RMPs) for license applications.
• Post-Marketing Expertise: We ensure ongoing pharmacovigilance activities to continuously monitor product safety.
• Streamlined Solutions: Pharmacovigilance outsourcing is a cost-effective option. We become your one-stop shop for all PV and regulatory needs.

Lariox Pharmacovigilance Services:

• Local PSMF & SOP development
• 24/7 QPPV & Back Up availability
• SDEA revision and preparation
• Quality system and archiving for both hard and soft copies
• Backup procedures and business continuity plans
• Literature screening
• Processing and assessment of ICSRs for local products
• Data management using Excel sheets
• MedDRA coding for marketed local products
• RMM and special PV activities (e.g., DHCP, targeted questionnaires)
• Response to EPVC requirements
• Training for client staff on receiving ICSRs for marketed products
• National Display RMP development
• National Appendices for imported products
• Re-registration document preparation and submission
• Reconciliation with involved parties