Pharmaceutical translation services

Our certified pharmaceutical translation services in US

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Both in pharmaceutical material created abroad being translated for the United States market and in pharmaceutical content created in the U.S. and translated for distribution around the world, Espresso Translations is your dependable source for prompt, affordable pharmaceutical translations in the relevant languages. We work with only top-notch translators who boast specialized knowledge of the pharmaceutical industry and its medical and scientific terminology, plus experience and training in the pharmaceutical market and its protocols and procedures in the U.S. and internationally. Espresso Translations can also provide certified translations as needed: just get in touch with us for a free quote.

You benefit in three key ways when you get pharmaceutical translation services from Espresso. You can expect:

1. The best professionals in pharmaceutical translations
2. Competitive, transparent pricing
3. Fast standard delivery as well as expedited services 

Feature	Description
Service Type	Translation services for pharmaceutical documentation
Supported Languages	Italian, English, Spanish, French, German, Chinese, Japanese
Specialization	Pharmaceutical and regulatory terminology
Translation Method	Professional human translation with expertise in the pharmaceutical sector
Delivery Time	Variable based on complexity and language (typically 3 to 7 days)
Accepted Formats	Word documents, PDFs, informational leaflets, compliance documents
Quality Assurance	Included in the service, with review by experts in the pharmaceutical field
Additional Services	Certified translation, localization for specific markets, regulatory assistance

Professional pharmaceutical translations approved by the Ministry of Health

What are pharmaceutical document translations?

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Translating pharmaceutical documents or text is a type of scientific translation. As such, pharmaceutical translations require a fairly high level of background knowledge about the pharmaceutical industry and the related terminology in two languages. This is necessary in order to produce a document in the target language that uses exactly the right terminology and does not introduce any inaccuracies or misunderstandings.

Read on to understand the importance of pharmaceutical translations and why they call for so much expertise and care. Pharmaceutical translations must be done by qualified professionals because of the criticality of the information being conveyed, because pharmaceuticals are so important to human health and scientific progress. These translations make it possible to exchange, internationally and interculturally, a variety of information on the results of research and clinical trials, the marketing and commercialization of new medicines, and enabling joint ventures in the pharmaceutical and public health sectors. The clear sharing of pharmaceutical information calls for the ability to localize text and a familiarity with the national and international regulations regarding pharmaceuticals.

Who is likely to need pharmaceutical translations? Obviously, pharma companies and any company involved in the manufacture and distribution of pharmaceuticals benefit from proper pharmaceutical translations. Such professional translations are also necessary for regulatory bodies, contract research organizations (CROs) and hospitals. Pharmaceutical translations are also often useful to universities, research institutions, the U.S. Food and Drug Administration (FDA), AIFA, the Italian Medicines Agency, and many similar institutions.

Why is pharmaceutical translation crucial?

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What is at stake in pharmaceutical translation is nothing less than human health and safety. Every bit of text in the usage instructions provided as a medicine package insert must be both scrupulously accurate and crystal clear to the reader to avoid possibly serious harm to the end user of the pharmaceutical product. In this type of translation, simply converting the text from one language to another is not enough, because tiny details can make a huge difference when public health depends on them, and preserving every nuance of the original writing calls for considerable expertise and experience.

Let’s consider what could go wrong because of an improper pharmaceutical translation, and then trace the problems caused by one case of culturally incorrect translation.

The trouble caused by an error in a pharmaceutical translation can affect public health, and missteps in public health can have serious (and costly) legal repercussions. In addition, regulations in the field of pharmaceutical manufacturing are exacting because of just this type of possible menace to health and safety. A failure to meet regulations can result in financially damaging fines and considerable embarrassment. All these factors highlight the vital need to rely on properly qualified, highly experienced translators with expertise in medical/scientific topics and an understanding of the regulatory background that applies.

A case in point of an inaccurate pharmaceutical translation is one excessively literal translation for the Italian market that caused a lot of consumer mistrust in 1995.

In this text, the definition of generic drugs in the original English was “a drug whose formulation is not protected by a patent, with the generic name of the active ingredient.”

Italian citizens were a bit troubled by this wording, because the word “generico” (generic) has a less than encouraging connotation in Italian. The first attempt at a better choice of word was “equivalente” (equivalent) in place of “generic” in Italian law no. 149 of November 26, 2005, but this measure failed to reassure Italian consumers.

In the next step in damage control, Italian Legislative Decree no. 219/2006 defined a generic drug as “a drug that has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference drug, as well as bioequivalence with the reference drug demonstrated by bioavailability studies.”

Many people in the field think that this medicine’s sales are still lagging due to the first insensitive translation. We will leave to your imagination the financial toll of this translation misstep, but you can be assured that it was significant.

Are there specific regulations for pharmaceutical translations?

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The technical terminology in the pharmaceutical field is complex not just because of the medical verbiage but also because of the regulatory context. The need to protect public health has resulted in best practices in pharmacovigilance that require translations to be clear to the average reader using a pharmaceutical product.

In order for a regulatory agency to grant authorization to market a pharmaceutical, the manufacturer must submit a lot of material such as clinical study documentation, validation records and trial results. Copies of all these documents must also be submitted in the languages relevant to the markets the drug will be sold to. Such translations are governed by regulations issued by local regulatory agencies such as the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER), the European Medicines Agency (EMA), or the Italian AIFA. 

Thus, pharmaceutical translations are far more complicated than a simple package insert: they can help bring a drug to more of the world. A health care product for international sale must comply with the specific labeling standards in each country. These standards apply to the descriptions in product leaflets (PIs) and the summaries of product characteristics (SPCs), and this naturally means that all labeling must be translated into the languages used in the countries where the pharmaceutical product will be marketed.

Example of a certified translation of pharmaceutical document

What types of documents need translation in pharmaceuticals?

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Many types of pharmaceutical documents will typically need to be translated by a linguist who specializes in pharmaceuticals. The complexity of these technical translation projects is considerable, given the need for full compliance with regulations in many countries, and such projects often need to be guided by a project manager at every step of the way.

Some of the documents often encountered in this process could include:

a) Regulatory Documents

Regulatory agencies ask for specific information about every pharmaceutical product before a marketing authorization can be granted for that product. Drug companies can be required to submit documentation including:

• Pharmaceutical registration dossiers
• FDA/EMA approval forms
• Regulatory guidelines
• Certificates of authenticity

b) Technical and Scientific/Medical Documents

The technical and medical details on a medication are contained in the following types of documentation:

• Clinical trial and pharmacovigilance reports
• Clinical study protocols
• Scientific publications
• Instruction manuals for medical devices  
• Pharmaceutical patents  
• Articles for specialty journals

c) Patient and Medical Professional Materials

This can be any material that would be helpful for doctors, patients, and anyone who might use pharmaceuticals and pharmaceutical products, such as:

• Medication package inserts and pharmaceutical labels
• Patient information leaflets
• Manuals for healthcare professionals
• Informed consent forms
• Pharmaceutical company communications and marketing content  
• Analysis and treatment protocols

Which sectors benefit from pharmaceutical translation?

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Pharmaceutical translation will be necessary in a number of types of businesses and organizations that operate internationally. The primary ones are:

• Pharmaceutical companies, of course  
• Contract Research Organizations (CROs)  
• Institutions conducting clinical research 
• Distributors of pharmaceutical products  
• Government agencies and other regulatory bodies  
• Manufacturers of medical devices  

How can I ensure quality in pharmaceutical translations?

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In seeking appropriate professional providers of medical and pharmaceutical document translation services, look for the elements listed below:

• Translators who specialize in the healthcare industry and pharmaceuticals—this is key 
• Compliance with all applicable regulatory standards  
• UNI EN ISO certifications  
• Strict quality assurance measures at every step in the translation process  
• A clear policy on translation prices  
• A history of completing translations on time  

Below, we will discuss each of the above points further.

a) Specialized Translators

Translators with specialized training and experience are needed as an assurance of receiving translated text that is fully faithful to the original material in order to protect human health and safety. This is especially true with pharmaceutical translations, because pharmaceutical products are so important for public health and individual outcomes.

Look for the following:

• A team of translators with experience in the pharmaceutical field. Translators should be native speakers of the target language.
• A record of professionalism and knowledge in translation and interpretation
• Technical and linguistic education in medicine or science, biotechnology, chemistry, and the like.  
• Thorough familiarity with pharmaceuticals and relevant regulations

b) Quality Control Processes

The pharmaceutical sector is the branch of translation that requires the greatest control over both processes and final quality.

• Appliance of the ISO 17100 standard for certified translations
• Pharmaceutical/medical specialists to carefully check the translations and make corrections
• Glossaries and translation memories employed to ensure the consistency of the terms used

c) Compliance and Security

• Full regulatory compliance with FDA/CDER, EMA, and MHRA requirements 
• Encryption to protect confidentiality and personal data  
• Use of Non-Disclosure Agreements (NDAs) to protect intellectual property  

Please note that Espresso Translations strictly observes the points listed above in our pharmaceutical translation and localization services. Espresso is certified for ISO 17100 standards and uses the procedures necessary for that certification. For top-quality pharmaceutical and medical translation services, use the Espresso Translations quote request form for a prompt quote and the answers to your questions.

What do our clients say?

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Our accredited translation agency takes pride in its excellent customer service, which includes prompt support and comprehensive guidance from its project managers. Take a look at our customer reviews:

What are the technologies used in pharmaceutical translation?

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The appropriate use of translation technologies can be invaluable in achieving precision in quality pharmaceutical translations. These technological translation tools can root out translation mistakes, allow faster translation, facilitate quality management, and sort out vocabulary issues. The most popular computerized translation solutions for the accuracy of pharmaceutical translations include:

• Computer-Assisted Translation (CAT) tools like Trados, MemoQ, and Smartling
• Artificial Intelligence (AI) and Machine Translation Post-Editing (MTPE) for larger translation jobs
• Custom glossaries and databases of terms

Who provides pharmaceutical translation services?

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Regardless of the service provider, special pharmaceutical knowledge on the part of the translator is a crucial element. Beyond that, you may be unsure whether to use a translation agency or an individual (freelance) translator in the translation of pharmaceutical documents. Translation agencies can produce considerably better results for you in a number of ways. Keep in mind the following advantages of agencies:  

• Precise terminology
• Proven reliability  
• Compliance with and knowledge of international regulations  
• Speed with large translation projects that would be impossible for a freelance translator
• Customer assistance personnel

For all your pharmaceutical translation needs, you can always count on the translation team at Espresso Translations to provide the best in all these language services.