Initial Submission Activities

Dossier development and strategy – CPS is happy to offer suggestions on where and how to file including the most appropriate type of application.

Module 1 preparation including: filing application forms, Patient Leaflet (PL) preparation from the Summary of Product Characteristics (SmPC), mock-up and specimen creation, readability testing, Braille certificates and/or declarations as needed, providing expert signatures for both clinical and non-clinical works, Environment Risk Assessments (ERA) and finally, Pharmacovigilance services including the Risk Management Planning (RMP).

Slot booking – As different countries offer different timelines for available slots throughout the year. We can discuss your requirements and check the availability of slots in your chosen country/countries as well as booking slots on your behalf.

Medical translations of all product information from any EU language into any EU language – All of our translators and proof readers feature medical backgrounds with numerous years of experience in the field and always reference the latest Quality Review Document (QRD) templates for every translation.

Readability User Testing – Although English can now be accepted across almost all EU countries regardless of the type of procedure being filed, CPS can also attend to your local testing needs in specific languages as required.

Scientific advice – As registrations move from small molecule to large molecule applications, CPS can assist with obtaining or providing scientific advice with our SME status.