Assess
Local PV requirements · Gap analysis · Country-specific roadmap
Local Pharmacovigilance Set-up
Bpharma builds compliant local pharmacovigilance systems that connect your global PV organisation with country-specific requirements.
Enter New Markets. We Help You Get PV-Ready.
Expanding into a new market brings new pharmacovigilance responsibilities.
Every country may have different requirements for local PV representation, safety reporting, literature monitoring, regulatory intelligence, risk minimisation, documentation and interactions with health authorities.
Bpharma helps pharmaceutical and biotechnology companies establish a compliant, practical and operational local pharmacovigilance system that connects with their global PV organisation.
The local PV organisation should operate as an extension of your global safety system. Bpharma establishes clear interfaces to support the accurate, consistent and timely flow of safety information between local and global teams.
Country-specific feasibility and service availability are confirmed for each project.
You enter the market. We help you get your local PV system ready.
In detail
Everything you need for local PV compliance
Global standards. Local expertise. One connected PV system.
Establish
Local Qualified Person for Pharmacovigilance (QPPV) / Local Safety Officer (LSO) · Deputy & back-up · Local expertise
Connect
Global & local processes · Safety data flows · Governance & escalation
Comply
Local PV obligations · Inspection readiness · Ongoing oversight
Scope
Local PV system set-up
Local PV
- Local QPPV
- Local Safety Officer
- Local PV Contact
- Deputy Coverage
Monitoring
- Local Literature
- Regulatory Intelligence
- Safety Monitoring
- Regulatory Changes
Safety operations
- Individual Case Safety Report (ICSR) Processing
- Medical Review
- Local Submissions
- Reconciliations
Compliance
- PV Compliance
- Audit Support
- Inspection Readiness
- Corrective and Preventive Action (CAPA) Support
We Don’t Just Set It Up. We Keep It Running.
A flexible end-to-end model supporting your local PV obligations from initial market entry through business-as-usual operations.