Pharmaceutical Translations
Recent challenging projects
Recent Challenging Projects
High-volume, certified translation project
Our client:Â A pharmaceutical company looking to register a pharmaceutical product in the South-Asian market
Language pairs:Â German into English
Key persons:Â Regulatory affairs managers and production managers
Type of documents:Â Batch records, GMP documentation and CTD
Tools and software:Â ABBYY FineReader and CAT tools
Volume:Â Over 100 PDF files containing more than 8,000 pages, with a total of 2 million words
Delivery time:Â 6 months
Intended audience:Â Regulatory authorities
Key challenges:
Solution:
Because of the volume of work and tight deadline, we assigned the documents to 10 translators specialising in pharmaceutical quality assurance documentation. Once 20% of the volume had been translated, we had a team of two linguists review the translation.
In order to ensure consistency between the files, we used the reviewed translations to create a glossary and term-base which were approved by the client. Whenever the revisers ran a quality check, the software could pick out any discrepancies between the translation and the term base for guaranteed consistency.
The tools we use also allow continuous, real-time monitoring of our translators’ progress. Any delays are flagged by the system and the project manager is immediately notified so they can get the project back on track. This technology paired with experienced translators allowed us to deliver this high-volume project on time.
Because we follow the ISO 17100:2015 translation process, we were also able to provide our client with a Certification of Accuracy according to regulatory requirements.
Complex variation in an MRP procedure
Our client:Â A pharmaceutical company submitting a complex variation in 5 countries
Language pairs:Â English into German, Dutch, Norwegian, Swedish, and Finnish
Key persons:Â Regulatory affairs managers and Member State authorities
Type of documents:Â Word document with track changes
Tools and software:Â CAT tools and WinAlign
Volume:Â 15,000 words
Delivery time:Â 5 days
Intended audience:Â Healthcare professionals and patients
Critical issues:
Solution:
This project was especially difficult due to the high volume of track changes. These changes were also very complex, requiring a lot of attention to detail. We knew that if we took a standard approach, the project would not be completed within the required timeframe.
However, because this project was for combined product information documents, we noticed that the changes made were very similar across each of the pharmaceutical forms. So, how did we use these repetitions to our advantage?
The first step was to treat the project as a clean translation with no track changes. Because we did not translate the initial product information, we used this to create a translation memory. This was done by aligning the original source text with the initial target text for each of the languages.
Once we had created the translation memory, we accepted all the track changes and ran this clean variation text through our CAT tool. Sentences that were not affected by track changes were identified by the CAT tool as 100% matches. Those that were affected by the track changes appeared as fuzzy matches or new text, making them easy to identify.
But the main advantage was that because we were using with a CAT tool, we could also benefit from repetitions. Where a change was made in one section, this would then be automatically made in other sentences where the original text was repeated. This significantly reduced the word count, allowing us to complete the project within the requested timeframe.
Upon completion, we generated the track changes by comparing the final target text with the initial target text. The client was very happy, and the authorities only made some minor changes to the translation.
