QRD Product Information Translation

At Novalins, we have vast experience when it comes to Regulatory Affairs translation, especially for the translation of Patient Information Leaflets (PILs), Labelling and Summary of Product Characteristics (SmPCs) required by the European Medicines Agency (EMA) for Marketing Authorisation Applications and Variations, in the frame of:

  • Centralised Procedure (CP)
  • Decentralised Procedure (DCP)
  • Mutual Recognition Procedure (MRP)
  • Referral Procedure
  • Type Ia/Ib and Type II Variations to existing Marketing Authorisations

When it comes to translating Product Information documents, Novalins has a well-established reputation for quickly providing multilingual translations following the latest QRD template in all European languages. These translations are not only technically and linguistically precise, but also culturally and audience adapted, as well as fully compliant with all regulatory and industry requirements set by the EMA and national medicine agencies.

Additionally, thanks to our wide network of specialized medical translators, we are able to deliver multilingual translations of Product Information within very tight deadlines, and therefore systematically meet the customer’s agenda set by the authorities.

We help our customers translate pharmaceutical products into all EU languages including Croatian as the nation of Croatia has recently joined the European Union. Our team is made of regulatory affairs specialists who have a solid understanding of document specificities and they make sure these documents comply with all EMA standards when it comes to layout, format, terminology, style, readability and content. The final products are translations that are in line with latest QRD template of the target language and follow terminology standards (medDRA and EDQM) and guidelines.

As well as providing the above services, we also assist regulatory affairs specialists with the following main solutions:

  • Medical writing (PIL writing / reviewing)
  • Medical translation
  • Mock-up creation
  • Generation of PDF versions of the Product Information
  • Updates of PI according to the latest QRD template
  • Readability Testing of PILs
  • Clinical translation
  • Medical transcription
  • Medical language translation of the Common Technical Document (CTD module 1, CTD module 2, CTD module 3, CTD module 4 and CTD module 5)

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