Do you follow the EMA QRD templates?

Yes. I use the current Portuguese version of the QRD templates and the standard terms for dosage forms and routes of administration, unless the client instructs otherwise.

Do you translate medical device documentation?

Yes: instructions for use, labelling and documentation for in vitro diagnostic devices covered by the IVDR.

Regulatory translation: SmPCs, package leaflets and labelling

Product information for a medicine in Portugal follows the EMA QRD templates and the terminology accepted by INFARMED. A package leaflet has to comply with those templates and still be clear to the patient reading it at home.

I translate and review this documentation against the QRD templates, standard terms and client references, and keep the SmPC, leaflet and labelling for the same product consistent with each other.

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What it covers

Summaries of product characteristics (SmPCs)
Package leaflets and labelling, following the QRD templates
Medical device and in vitro diagnostic documentation (MDR/IVDR)
Promotional and training materials for healthcare professionals

Frequently asked questions

Do you follow the EMA QRD templates?: Yes. I use the current Portuguese version of the QRD templates and the standard terms for dosage forms and routes of administration, unless the client instructs otherwise.
Do you translate medical device documentation?: Yes: instructions for use, labelling and documentation for in vitro diagnostic devices covered by the IVDR.

Other fields

For a quote, please include the document type, language pair, approximate volume and deadline. If possible, attach the file or an excerpt.