european pil user testing in most languages

Package Information Leaflet (PIL), Summary of Product Characteristics (SmPC) Services and Medical Writing

Expert medical support Module 1 for centralized procedures, decentralized procedures, mutual recognition procedures and national procedures.

PIL writingPIL Services:

  • Package Information Leaflet writing
  • Reformatting of PILs to QRD
  • Mock Up creation

SmPC services:

  • SmPC writing from the BE studies
  • Creation of a core SmPC for generic applications
  • Sourcing and translating of reference product SmPCs
  • Harmonisation of SmPCs for generic applications

Medical Writing:

  • Clinical overviews
  • Non-clinical overviews

Preferred Readability Testing Providers for: