REGULATORY & COMPLIANCE
Pharmacovigilance
Product safety, throughout the lifecycle.
THE SERVICE
Product safety, throughout the lifecycle.
Support the systems and processes behind ongoing medicine safety. Our pharmacovigilance services help businesses organise safety information, reporting activities and inspection preparation.
The appropriate scope depends on your product portfolio, markets and responsibilities. We can discuss a focused activity or broader support for establishing and maintaining your safety processes.
How we can support you
- 01Establish and maintain pharmacovigilance systems
- 02Manage safety cases and reporting workflows
- 03Support safety-database operations
- 04Review signals and risk-management activities
- 05Prepare aggregate safety reports
- 06Monitor relevant scientific literature
- 07Coordinate local QPPV and pharmacovigilance support
- 08Prepare for audits and regulatory inspections
WORKING TOGETHER
A clear, collaborative process.
01
Understand
Review your product, business goals and market context.
02
Define
Agree the deliverables, responsibilities and project scope.
03
Coordinate
Bring the relevant documentation, people and activities together.
04
Review
Keep the next decisions and follow-up requirements in view.