In the life sciences industry, it cannot be overstated how critical accurate regulatory translation is. One small error in a translated document can lead to regulatory delays, market rejections, or potential legal consequences, all of which cost time and resources to sort out. With global markets and diverse regulatory requirements, and the pressure to go to market, it's beneficial for life sciences companies to understand common translation pitfalls to avoid that can derail product approvals. Here are five to watch out for:

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1. Misunderstanding Local Regulatory Requirements

Regulatory bodies like the EMA, FDA, and PMDA each have unique expectations for submissions. A common mistake is assuming a translation that works for one region or regulatory body will be acceptable for another. It's essential to work with linguists who understand the language, scientific terminology, and the specific regulatory requirements of the target country.

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2. Using Non-Specialist Translators

General translators may miss critical nuances in scientific or medical terminology. Life sciences documents, like clinical trial protocols, labeling, and package inserts, require a workable knowledge base of the general materials and complex concepts to ensure proper translation. Choosing linguists with life sciences expertise helps ensure accuracy and compliance.

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3. Ignoring Cultural and Linguistic Context

Literal translations can be risky and even dangerous in regulated content. For example, a term that’s commonly accepted in English might have no direct equivalent, or a misleading alternative, in another language, completely altering the initial intent. This can often be the case when AI or digital translation tools are the only resource being utilized for translation. Understanding how to localize content accurately while preserving regulatory meaning is crucial.

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4. Skipping Quality Assurance Steps

Even the best translators can make mistakes. Without proper review and quality control (such as back-translation,  in-country review, digital tools, or AI-powered translation), those mistakes can slip through and cause serious issues. Regulatory translation demands a multi-step quality assurance process to catch errors before submission. The right translation partner will have a process that is effective and efficient for your unique translation needs/ 

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5. Delaying Translation Until the Last Minute

Waiting until the end of the submission process to translate documents can lead to rushed work, errors, and missed deadlines. Regulatory translation should be integrated early, if possible, into your product development timeline to ensure everything is ready on time. However, we understand that things happen, and submitting to regulatory bodies isn't always a linear experience. That's why translation partners, like Riboexi, can offer variations and emendable translation packages that directly target your time-sensitive translation needs, getting you the materials you need without the extra cost and burden of full document translations. Finding a service provider that can work with you on your unique timelines and budget will make all the difference. 

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Why It Matters

In a field where precision is everything, regulatory translation can’t be an afterthought. At Ribolexi, we specialize in helping life sciences firms navigate the complexities of global regulatory translation with speed, accuracy, and compliance in mind.

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Need support with your next submission?

Get in touch with Ribolexi to learn how our team of expert linguists and regulatory specialists can help your content meet global standards.

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