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Tomedes Delivers High-Stakes Product Information Translation for UK Compliance

Tomedes delivered accurate German-to-UK English PI translations for MediCura in 5 days, ensuring regulatory compliance and consistent medical terminology.

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Product Information Translation for UK Compliance

April 10, 2025

Our client

Company name: MediCura (Pseudonym)
What does the company do?
MediCura is a European pharmaceutical manufacturer producing treatments for thyroid-related conditions.
Deadline set by the client: 5 days
What do they need?
They needed two product information (PI) documents translated from German to UK English in just five days. These files contained dosage and safety details for levothyroxine, a thyroid hormone treatment.

The Challenges

Every high-stakes translation project comes with its own set of pressures, and this one was no exception. From time constraints to technical precision, the challenges we faced demanded flawless execution across every phase of the workflow.

First, the full project—including translation, expert review, and final formatting—had to be completed within just five days. This timeline left no margin for delays, making speed and coordination absolutely critical. With multiple stakeholders involved on the client side, any delay on our end could have disrupted their regulatory filing schedule.

Second, the two product information (PI) sheets addressed separate dosage levels of levothyroxine, each with slight variations in instructions, composition, and patient usage details. We had to maintain uniformity in tone, structure, and terminology across both documents while carefully preserving content-specific nuances. Achieving this balance was essential for both internal alignment and external compliance reviews.

Last, every term had to align with UK medical and pharmaceutical regulatory standards, which are both rigorous and highly specific. Even minor linguistic deviations could have triggered red flags during approval processes or misinterpretations by healthcare professionals. The content required precision not just in language, but in its legal, medical, and cultural context.

Why Tomedes?

Tomedes is a global translation company with deep expertise in medical translations, combining linguistic precision with medical and regulatory knowledge. That’s why we assigned a certified medical translator with proven experience in EU pharmaceutical terminology and German-to-UK English medical documentation. This ensured every dosage instruction, adverse effect, and regulatory phrase was translated with scientific precision and contextual accuracy.

To streamline the project from the start, we leveraged our proprietary Pre-Translation Toolkit, which identified key terms, flagged potential inconsistencies, and evaluated text complexity. This preparation allowed our linguist to work more efficiently and with greater clarity, reducing the need for revisions. Meanwhile, our 24/7 customer support team kept communication flowing, securing client approvals in real time and ensuring no time was lost across global time zones.

The solution

To ensure a successful outcome for this high-stakes medical translation project, Tomedes implemented a meticulous, multi-phase approach focused on accuracy, consistency, and speed. By combining advanced pre-translation tools with expert human oversight, we delivered fully compliant German-to-UK English PI documents right on schedule.

First, to ensure a smooth process, we started with our Pre-Translation Toolkit. It helped us identify key terms, check grammar, and spot any complex sections. This allowed us to choose the right medical translator and build a consistent glossary for both documents.

Second, a native UK English medical translator handled the translation using the prepared glossary. This ensured consistency in tone and accuracy across both PI documents. A second medical editor reviewed the work to make sure it met UK regulatory standards.

Finally, we kept in constant contact with MediCura to confirm terms and get fast approvals. This helped us avoid delays and kept everyone on the same page. We delivered fully formatted DOCX and PDF files on time, ready for immediate regulatory use.

The result

The project was successfully completed within the five-day deadline, enabling MediCura to stay on track with its internal regulatory and product rollout schedule. Timely delivery was critical, and Tomedes met this challenge without compromising quality. This punctual execution reinforced the client’s confidence in our ability to handle high-stakes, time-sensitive medical translations.

In addition to meeting the deadline, we ensured seamless consistency across both product information documents. Despite the differences in dosage and usage instructions, the terminology, tone, and structure remained uniform—critical for both internal coherence and regulatory compliance. MediCura praised our team’s clear communication, linguistic precision, and streamlined workflow, highlighting Tomedes as a trusted partner for future pharmaceutical translation needs.

Conclusion

Tomedes brings together expert linguists and innovative AI tools to help pharmaceutical companies meet their translation challenges head-on. Whether you need to translate product information, patient leaflets, or regulatory submissions, we ensure precision, speed, and compliance—every time.

Need accurate, fast, and regulation-ready medical translations? Tomedes combines expert linguists with smart technology to deliver results you can trust. Get in touch today for a free consultation and see how we can support your next pharmaceutical project.

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