SAFETY SERVICES / 09
Global PV & Regulatory Safety
Align safety responsibilities, specialist input and reporting support across the markets in your scope.
Discuss this service
What this service covers
- International PV requirements
- Global safety operating models
- Regulatory safety submission support
- Pharmacovigilance agreements
- Cross-border vendor coordination
- Market-specific safety requirements, including China where appropriate
Potential deliverables
- Market-specific responsibility map
- Safety agreement and submission support plan
- Cross-border provider and handover framework
What to bring to the discussion
- Products, development stage and target markets
- Local representation and reporting arrangements
- Data access, language and cross-border requirements
Qualified specialists, delivery arrangements and responsibilities are agreed before contracting.
WHAT WE CAN SUPPORT
Expertise for your scope.
- International PV requirements
- Global safety operating models
- Regulatory safety submission support
- Pharmacovigilance agreements
- Cross-border vendor coordination
- Market-specific safety requirements, including China where appropriate
Potential deliverables
- Market-specific responsibility map
- Safety agreement and submission support plan
- Cross-border provider and handover framework
Start with your context
- Products, development stage and target markets
- Local representation and reporting arrangements
- Data access, language and cross-border requirements