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 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: