Pharmaceutical Translations

Recent challenging projects

High-volume, certified translation project.

Our client: A pharmaceutical company looking to register a pharmaceutical product in the South-Asian market

Language pairs: German into English

Key persons: Regulatory Affairs Managers and Production managers

Type of documents: Batch Records, GMP documentation, CTD

Tools and software: ABBYY FineReader, CAT tools

Volume: Over 100 PDF files containing more than 8,000 pages with a total of 2,000,000 words.

Delivery time: 6 months

Intended audience: Regulatory Authorities

Key challenges:

  • High-quality, certified translations
  • Accuracy and consistency of the appropriate terminology
  • Complex source documents with complex images containing text that needed to be translated
  • Organising files while using a variety of different software tools
  • Guaranteed delivery times

Solution:

Because of the volume of work and tight deadline, we assigned the documents to 10 translators specialised in pharmaceutical quality assurance documentation. Once 20% of the volume was translated, we assigned the translation for review to a team of 2 linguists. To ensure consistency between the files, a glossary and term-base was created and approved by the client. Whenever the revisers ran a quality check, the software would pick out any discrepancies between the translation and the term base. We guaranteed consistency of the translation.

The tools we use allow continuous real-time monitoring of the progress of the translators. Any delays in the process are flagged by the system and the project manager is immediately notified to initiate corrective measures. This technology combined with the use of translators with experience in the specific topic of the project, allowed us to deliver the high-volume project on time.

Because we follow the ISO 17100:2015 translation process, we provided our client with a Certification of Accuracy, in line with the regulatory requirements.

Looking for translation specialists to help with your project? Get in touch today and let’s start your own success story. Click here for a free consultancy with one of our experts.

Complex Variation in a MRP procedure

Our client: A pharmaceutical company submitting a complex variation in 5 countries.

Language pairs: English into German, Dutch, Norwegian, Swedish, and Finnish

Key persons: Regulatory Affairs Managers, Member State authorities

Type of documents: Word document with track-changes

Tools and software: CAT tools, WinAlign

Volume: 15,000 words

Delivery time: 5 days

Intended audience: Healthcare professionals and patients

Critical issues:

  • Strict deadlines
  • Complex track changes

Solution:

The project was very difficult because the volume of track changes was very high and the changes were very complex, requiring a lot of attention to detail. We knew that with a standard approach, the project could not be completed in the required time. However, we noticed that because it was a combined product information, the track changes were very similar for each of the pharmaceutical forms. So how do you benefit from repetitions when you work in track changes. See how we did it:

We treated the project as a clean translation (no track changes). Because we did not translate the initial product information, we created a translation memory. We aligned the initial source text with the initial target text for each of the languages. Once the translation memory was created, we ran the clean variation text (all track changes accepted) through our CAT tool. Sentences that were not affected by track changes were identified by the CAT tool as 100% matches, while sentences affected by track changes appeared as fuzzy matches or new text. However, because we were working in a CAT tool, we could also benefit from repetitions. The word count was thus decreased significantly, allowing us to complete the project in the requested timeline.

Upon completion, we generated the track changes by comparing the final target text with the initial target text before the variation.

The client was very happy, and the authorities had only minor changes to the translation.

Looking for translation specialists to help with your urgent translation project? Get in touch today and let’s start your own success story. Click here for a free consultancy with one of our experts.

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