Services | Exphara Bioresearch PLC — Pharmacovigilance & Drug Safety

End-to-End Drug Safety

Comprehensive Solutions Across the Drug Safety Spectrum

From single-case processing to full pharmacovigilance system ownership, our services scale to the needs of sponsors, marketing authorisation holders and distributors — all delivered to global regulatory standards.

01 — Core PV

Pharmacovigilance

ICSR End-to-End Case Processing
ICSR Collection Services 24/7
Signal Detection & Management
Aggregate Reports (PSUR / PBRER / DSUR)
Pharmacovigilance System Master File (PSMF)
PV System & Overall Case Management

02 — Medical

Medical & Safety Services

Medical Review & Assessment
Medical Information & Call Center (MICC)
Local Literature Search
Global Literature Search
Literature Surveillance
Drug Safety Mailbox Management

03 — Regulatory

Regulatory & Compliance

PV System Setup & SOPs
Regulatory Intelligence in PV
GVP Audits & Inspection Preparedness
QPPV & Local Contact Person for PV
DOSSIER Preparation & Regulatory Affairs
Audit & Inspection Readiness

04 — Partners

Partner & Distributor Support

PV Services for Distributors
Local Contact Services
SDEA (Safety Data Exchange Agreements)
Training & Capability Building
End-to-End PV Solutions
Medical Device Safety Support

05 — Technology

Data & Technology

Safety Database Management
Analytics & Safety Reporting
Secure & Compliant Systems
Database Migration & Reconciliation
Dashboards & Performance Metrics
System Validation Support

06 — Advisory

Advisory & Consulting

PV Consultancy
Risk Management & RMP Support
Project Management
Audit Support & Gap Assessments
PV Strategy & Process Optimisation
Regulatory Advisory

Our Services