Health and FitnessMedical

What are Regulatory Translation? Why Hire Professional Regulatory Translators?

Are you looking for professional medical document translation services? 

If yes, then you better hire regulatory translation translators for this job. Medical data is more sensitive in nature, and that’s why you have to be extra careful while doing medical translations.

Be it translations for clinical trials, or patient test reports, your translations should be in compliance with the international healthcare standards.   

Pharmaceutical  companies, medical product manufacturers, and healthcare providers use regulatory translation services to translate their documents. 

Translations are done considering the multilingual regulatory principles to maintain the accuracy and clarity of the content. For this, you must hire professional regulatory translation professionals with a high level of medical knowledge and experience in the field. 

In this article, we’ll discuss the regulatory translation and why we should hire professional regulatory translators to do medical translations. Read this article to know about regulatory translations and what their significance is. 

What are Regulatory Translations?

Regulatory translations are the translations of pharmaceutical, medical,and healthcare documents, in compliance with international regulatory bodies. To make your medical documents understandable for the international medical authorities, the best option would be professional regulatory translation services. 

These translations follow the ISO standards to fulfill the international regulatory requirements while doing professional medical document translations. Documents, such as labeling, SmPCs, PiL, SoPs, and validations protocols should be done under regulatory translations. 

Moreover, international medical bodies also see professional regulatory translations as an authority. To maintain the clarity and authority of medical translations, it is also recommended to get professional medical document translation services. 

Why Hire Regulatory Translators?

As compared to any other type of translation, medical translations are more complex and sensitive in nature. Regulatory translators understand the medical intricacies and have linguistic skills to perform in-context translations for the targeted region. The syntax, writing style, and tone of medical translations are also different from other translations. 

Having professional regulatory translation is a must to avoid any problems and penalties in a foreign country. For instance, if you want to translate an SmPC (Summary of Product Characteristics) text, you have to use professional terminologies to describe side effects and other elements of the documents. 

Moreover, hiring professionals with good language proficiency reduces the chances of unnatural phrases and robotic content.

These translators fluently translate the documents and enhance the readability of translations without compromising the regulatory principle. 

How to Choose Medical Translators? 

To do the translations, your translators must have an extensive understanding of this subject. Translators should be familiar with international medical standards and processes in general. 

Every region can have its own medical communication standards, so this is also something that translators must be aware of. As per IMIA, medical documents should be translated by professional medical translators with language proficiency, cultural understanding, and medical knowledge. It would be even better if you hire native or near-native translators. 

You can also choose someone with degrees in medicine, life sciences, and pharmaceutical. Medical qualifications allow your translator to better understand the context of medical documents and generate more accurate translations. 

However, just having a medical degree is not the only criteria for the selection of translators. To do the translations, they would need professional training and only with good experience in the field, they are able to produce quality translations. 

How do Professional Translators ensure Quality?

Once the translations are done, proofreading of entire documents is compulsory to ensure that the final version of the translation file is perfect and error-free. The person who proofread the translations should have at least equal qualifications and experience to the original regulatory translator.

If the editor has more experience and a higher educational degree, it would be even better. The purpose of proofreading is to improve the overall quality of translation by eliminating errors, and ambiguities. 

Your proofreader should understand the purpose of the medical document, the client’s instructions, formatting rules, and the standard terminologies to be use in the translations. 

It is important to test your translations through multiple proofreading phrases because our purpose is to translate the meaning not the words. Moreover, you must provide the translation glossaries to the proofreader, so he already knows the abbreviations, brand terminologies, acronyms, and other definitions related to your company. 


Considering the fact that medical translations are more sensitive, you have to carefully choose the right regulatory translator to get your translation job do. Most people still don’t understand the significance of professional regulatory translations. 

They use open-source software or hire a bilingual person to do the medical translations.

 It is quite risky to hand over your medical documentation to a non-credible resource. It would not just result in poor translations but can lead to higher risks and even life threats because of ambiguous data. 

Your translator must have a higher level of understanding of the field and know the principle and formatting rules to do medical translations. 

When it comes to translating a patient’s test report or diagnosis, you can’t afford miscommunication because it can lead to major health risks. So, make sure you get your medical document translation services from a reliable service provider.

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