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A Story of Success

Complex Translation Project: New application for the authorisation of a medicinal product in European Union

Learn how we helped a pharmaceutical company successfully submit their product information in all EU languages as part of a centralised procedure.

Our client: A pharmaceutical company based in Europe

Language pairs: English into all EU languages

Description: Our client was submitting a new application for the Marketing Authorisation of a new medicinal product

Key people: Regulatory affairs manager, European Medicines Agency, rapporteurs and EU Member States

Type of documents: Product information, including summary of product characteristics, labelling and package leaflet

Volume: 71 pages in Word format

Delivery time: 

• Pre-Opinion: Draft translation of the product information to be completed between Day 180 and Day 210
• Post-Opinion: Translation of the adopted product information to be completed between Day 210 and Day 215
• Post-Opinion: Final translations with tracked changes, incorporating the Member States’ comments to be delivered by Day 235

Target audience: 

• Healthcare professionals and patients

Key challenges:

• Producing a quality translation while meeting strict deadlines according to the linguistic review time frame for a new application
• Complying with QRD documents, while also ensuring the accuracy and consistency of the appropriate terminology for the target audience
• Absolute secrecy and total confidentiality restrictions requiring cyber-security measures

Solution:

We received an English draft of the product information on Day 185 of the procedure. Together with the client, we performed an analysis of the text to ensure that there was no figurative language or ambiguity. We focused on any potentially confusing passages, which would have therefore been confusing in the target language.

The file was then uploaded into our CAT tool, where translators had access to all the references they needed for a high-quality translation. This included the latest QRD templates, MEDDRA and EDQM terminology, guidelines and dictionaries.

We put together a translation team of subject matter experts who had previously demonstrated their expertise, having received highly-rated feedback when working on previous procedures. We also selected translators who had previously worked on similar products from the ATC code.

On Day 210, we received the final text and implemented the final changes by Day 215. We delivered the adopted product information and Annex A in all EU languages on time.

On Day 220, our client sent us feedback from the Member States. We checked their comments and discussed any sections where we disagreed with their review. Once everyone had reached an agreement, we finalised the product information translation and provided the client with proof of the agreement. We created the final Word files with tracked changes, along with clean PDF files containing the required bookmarks, all named according to the checklist. We delivered the files to our client on Day 232.

Happy ending: 

There was no time to market delay, and no issues with the quality!