Professional Regulatory Affairs Translation Services

Meeting international regulatory standards is critically essential for medical device manufacturers, pharmaceutical companies, and CRO firms to tap into global markets. The international regulatory bodies have stringent rules and regulations that are unlikely to be met without assistance from regulatory compliance translation. That’s where Mars Translation can help.

Mars Translation is a regulatory translation company that has gained popularity in the field of medical sciences through high-end certified regulatory translation services.

  • Subject Matter Expertise
  • Advanced Background Knowledge
  • Experience (in PMDA, CFDA, FDA, etc)
  • Fast Turnaround
Regulatory Translation Services

Why You Need Regulatory Compliance Services

There’s no room for errors in regulatory submissions. If there are any errors made, it could massively lead to a loss of customer trust and could have fatal consequences. Therefore, choosing an unprofessional or uneducated native speaker for your regulatory materials translation is not a sensible decision.

Language translation for regulatory affairs is a highly specialized and complex field that requires accurate and precise translation at each level of your business. Therefore, it’s recommended to take professional assistance in this regard. Looking for reliable regulatory affairs translation services? Mars Translation is your go-to option!

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All-In-One Translation Solution For Regulatory Documents

Our professional regulatory translation services determine the value of your products so that they can gain their respective recognition in the marketplace. 

  • Instructions for Use
  • Package Forms
  • Drug Product Information
  • Compliance translate
  • Standard Operating Procedures
  • Documentation
  • Regulatory Correspondence
  • Regulatory Dossiers Packaging
  • Regulatory dossiers translations
  • Patient Prescribing Information
  • Summary of Product Characteristics
  • Labeling Common Technical Documents
  • Chemistry, Manufacturing, and Control Documentation
  • Fast And Accurate Global Regulatory Submissions Translations
Medical regulatory documents translation
Professional regulatory Translation services

Regulatory Translation For NMPA, EMA, and PDMA

For the last two decades, we have successfully raised a standard in the market by providing customers with top-tier medical regulatory documents translation

  • Regulatory submission translation for NMPA: If you want to expand your business to China, you will need to translate your documents for the Chinese regulatory body NMPA or National Medical Products Administration.
  • Regulatory translation services for EMA: We can also help you make a successful entry into the European Union. Experts in all 24 languages of the European Union, we would make your journey for approval of EMA (The European Medicines Agency) easy and quick.
  • Regulatory translation for PMDA: If you’re aiming to achieve regulatory compliance for pharmaceutical products, our regulatory translation agency would help you translate all documents like:
    • Drug inserts
    • PROs (patient-reported outcomes)
    • COAs (clinical outcome assessments)
    • Medical patents
    • Packaging labels, and much more
    • Regulatory dossiers translations
    • Patient Prescribing Information

Get your regulatory documents translated by top-rated translators at affordable rates.

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Regulatory Translation Company

Certain documents require approval for implementation and communication. These documents, called regulatory documents, are an integral part of the medical industry. Many countries, such as the USA and Japan, require that the dossiers and approval files for new medical products be translated and submitted in multiple languages for regulatory bodies to read and analyze them. 

The process for regulatory translation is a long one. This process starts with the collection of appropriate data from sources and the editing of this information to achieve the desired tone. After the regulatory translators have dealt with the translation of regulatory files, the text may have to undergo various levels of publication before being presented in the local language of the regulators. 

To ensure clarity and consistency in the regulatory translation, our subject matter experts pass your regulatory documents through a meticulous and efficient process of translation. After they are done with the translation of your files, these files undergo a quality assessment mechanism where other translators proofread the translated content for any errors. 

Since regulatory documents are of high importance and require extra precision, there is a need to translate these regulatory approval submissions for easy communication. Accurate translation of regulation approval submissions is of utmost importance due to these reasons:

  • Regulatory affairs related to approval submissions need to be verified and approved on time by regulatory authorities
  • The regulators or regulatory authorities may be present in other countries and may speak different languages, which is why there is a need to translate them accurately
  • Translation ensures the regulation approval submissions are understandable, accessible, and comprehensible to all relevant stakeholders, regardless of their linguistic or cultural background
  • If not translated properly, regulation approval submission documents can lead to serious consequences such as delays in the regulatory approval process, financial and legal penalties, as well as risks to patient safety.

The process of regulatory translation is important, requiring accuracy and high levels of professionalism from regulatory translators. Mars Translation provides highly professional subject matter experts with credible experience in delivering professional translations for regulatory files and documents. Our regulatory translators ensure accurate translations of regulatory documents, as they have expertise in technical language and regulatory compliance.

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