What we deliver
Core requirements
Part A safety information
Scientific safety assessment and a structured PIF prepared for market access, inspection and lifecycle updates.
Part B safety assessment
Scientific safety assessment and a structured PIF prepared for market access, inspection and lifecycle updates.
PIF gap analysis and compilation
Scientific safety assessment and a structured PIF prepared for market access, inspection and lifecycle updates.
Why Kompass Europe
Kompass Europe coordinates the commercial objective, technical evidence and market-specific obligation in one controlled workflow. The scope is confirmed before work begins, and material gaps are recorded so regulatory decisions remain traceable.
Where a local entity is legally required, the mandate and responsibility are documented. Where the service is advisory, the role is stated clearly without creating a misleading local-presence claim.