Main services
Quality for Pharmacovigilance
Thanks to its ISO-certifed Professionals, PharmaPartner provides all Pharmacovigilance Quality services required by law: Pharmacovigilance Quality System, audits, role of Pharmacovigilance Quality Assurance, and more.
Audit and Inspections
PharmaPartner performs pharmacovigilance audits (with ISO-certifed auditors) and can support Companies in creating, planning and putting in place corrective and preventing actions. PharmaPartner also supports Companies before and during Regulatory Inspections performing back office activities in order to warranty business continuity.
PSMF, SOPs
and SDEA
PharmaPartner supports Clients in creating and maintaining the PSMF according to quality requirements; we propose effective and efficient flow for information exchange to manage PSMF, SOPs and agreements with third parties.
Training
PharmaPartner provides Clients with training for Pharmacovigilance and Quality staff, offering In house or Open sessions; we also coach the identified personnel through customized programs.
Main services
- Pharmacovigilance Audits and Due diligence
- Standard Operating Procedures: creation and update
- Complete outsourcing of Pharmacovigilance service
- Complete outsourcing of Pharmacovigilance Quality Asurance service
- Pharmacovigilance Agreement (SDEAs/PVAs)
- Pharmacovigilance Training
- Role of QPPV, Pharmacovigilance QA, local QPPV representative, holiday coverage
- Eudravigilance: XEVMPD and ICSRv
- Periodic Reports – PBRER, PSUR, DSUR
- Monitoring of Italian Rete Nazionale di Farmacovigilanza
- Roles of QPPV, local QP, PVQA
- Computer System Validation
- Privacy management according to EU Regulations
- Risk Management Plan
- Scientific translations
- Regulatory services