QRD Template Update Service

Our medical writer will update your SmPC/PL and texts for labels in accordance with the current QRD templates for your CP or MRP/DCP. On request, you will receive the finished texts ready for your submission.

Our QRD template updates include the following services:

Updating of the product information by medical writers/special translators working in their respective mother tongues
Review by editors/specialist translators working in their respective mother tongues
Review of the revision by QRD experts
Checking of formatting with the use of a QRD checking program
Coordination of the team for each EU language
Optional during submission: Creation of “present-proposed” tablets
Optional during submission: Creation of PDF files and naming the files

We check

EDQM standard terms
MedDRA terminology
Standard sentences and headings
Excipient formulations
Formatting and file names in accordance with
EMA/524020/2007 “User guide on how to generate PDF versions of the product information – human“ and
EMA/62470/2007 “QRD convention to be followed for the EMA-QRD templates”
SI units, non-breaking spaces and hyphens
Standard translations in accordance with Appendix I-IV

Registrated to DIN EN ISO 17100:2016-05