Navigating the world of life sciences, accurate translation is essential and goes far beyond word-for-word replacements. And when it comes to preparing documentation for the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), choosing the right translation partner can be the difference between smooth regulatory approval and costly delays.

Between artificial intelligence (AI) translation features and other digital translation tools, subject matter experts, native language speakers, etc., how do you choose the right solution for your budget, timelines, and regulatory needs? 

At Ribolexi, we understand the unique demands of life science industries, particularly when it comes to EMA and FDA submissions. Here's what to look for when selecting a translation partner to ensure you're able to find a translation solution partner that works best for your needs: 

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Industry Experience Matters

Not all translation providers are created equal. Look for a partner with a proven track record in life sciences and regulatory translation. This suggests more than just translating documents, it means translators understand the scientific language, regulatory submission structure, and the expectations of agencies like the EMA and FDA. Knowing who is translating your scientific materials can make all the difference in how successful your translation partner is in getting you what you need. 

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Quality and Accuracy Are Non-Negotiables in Translation

This may seem to go without saying, but regulatory agencies demand precision. A mistranslation in a clinical trial report or a product label could lead to misinterpretation and serious setbacks at the very least. Costing you and your business valuable time, money, and resources, making corrections and sometimes resubmissions.  A translation partner that employs qualified translators with subject matter expertise and follows a clear quality assurance process, including review and proofreading by a second linguist and the incorporation of technology and automation tools where appropriate to maximize efficiency without compromising quality. 

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Compliance Knowledge Is Key for Document Translation

Your translation partner must be familiar with regulatory frameworks and guidelines, including those specific to EMA and FDA. This ensures your documents are accurate and compliant with formatting, terminology, and submission standards. This component can often be overlooked by services or AI-enabled technology, only looking to change the language. Having a partner that can offer the option of maintaining format and document integrity while translating will make all the difference when it comes to regulatory submissions. 

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Confidentiality and Security Must Be Guaranteed for Translations

You’re dealing with sensitive data! Trial results, product information, patient details, etc., all come with their own set of required security protocols and handling procedures. The right partner will treat your content with the confidentiality and compliance it deserves, using secure systems and strict data privacy protocols to protect you and the information being translated. Having this capability in your translation partner keeps the integrity and quality of your company intact and held to the highest standard. 

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Scalability and Timeliness Count Even With Translations

Regulatory timelines and turnarounds are tight, and missed deadlines or delayed documents can cost far more than a few days time. Everyone wants a translation solution that can handle large volumes of content quickly without compromising quality. But, the right translation partner with tailor the approach to maximize on your goals and business needs, adjusting where necessary to make sure your time, money, and resources are used as efficiently and effectively as possible.  Whether you’re submitting a few pages or hundreds of documents, your partner should be able to scale with you and adapt to match your translation needs at every step. 

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At Ribolexi, we combine life sciences expertise with top-tier translation services and technology to support your journey to regulatory approval every step of the way. Whether you’re submitting to a regulatory body or not, we’re here to help you communicate clearly, confidently, and compliantly, acting as your trusted partner in scientific document translation. 

Looking for a trusted translation partner? Contact us today to learn how we can support your next submission.