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Pharmaceuticals Translations

Unwavering commitment in the service of pharmaceuticals translation in 250+ languages to help bring new drugs to markets overseas.

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End-to-End Pharmaceutical Translations

With the global pharmaceuticals sector currently valued at over one trillion USD, demand for pharmaceuticals translations has expanded in both domestic and foreign markets, as international patients generate demand for new drugs. This expansion enables substantial growth throughout drug development, in multilingual clinical trials, drug production, and drug distribution, with forecasts for profitability in pharmaceuticals sector to increase.

However, as regions such as APAC, LATAM, and Europe become more accessible for the rest of the world, pharmaceutical companies will need to ensure that their pharmaceutical drugs are marketed with properly translated and localized medico-marketing materials. Beyond medico-marketing materials, the growing overseas demand for drug therapies and treatments means that pharma companies need to ensure that clinical trial documentation and regulatory documents are translated with the highest degree of accuracy and quick turnaround times. This not only prevents companies from losing millions for failing to comply with regulations, but also from potentially endangering patient lives if life-saving treatments are not available.

CSOFT Health Sciences’ global network of more than 10,000 in-country linguists and subject matter experts (SMEs) provides the highest-quality pharmaceutical translation services for all stages of the medication lifecycle in 250+ languages, from CTD/eCTD submission and phase 0-IV to clinical trial documentation to pharmacovigilance reports and medico-marketing materials.

Medical Document Translation

All phases of the medicine development lifecycle – from regulatory documents such as CTD/eCTD submissions and new drug applications (NDA) to clinical trial documentation and pharmacovigilance – involve significant document volumes that require high levels of accurate medical document translations with fast turnaround times. If such medical documents are not translated accurately and quickly, companies could fail to gain regulatory compliance, causing costly delays in the drug development lifecycle. Worse, a lack of accuracy could result in adverse outcomes for patients. CSOFT Health Sciences understands these concerns, and provides pharmaceuticals and other life science companies fast, high quality translations of CTD/eCTD submissions, research protocols, case report forms (CRFs), informed consent forms, FDA, EMA, and NMPA submissions, and other documents for the best ROI.

Learn more about our medical document translation services.

Pharmaceuticals require expert translations

Pharmaceuticals in Multilingual Clinical Trials

Clinical trials account for an enormous portion of the investment required to bring pharmaceutical drugs, medical devices, and innovative treatments to market in any country, making clinical trials translation solutions necessary when conducting trials overseas. For pharmaceutical companies expanding in overseas markets, clinical trial translation is crucial to meet local regulatory requirements. However, inaccurate translation risks regulatory viability in the target market, as well as potentially endangering patient safety and drug efficacy, making precise, high-quality translation an essential priority for all stakeholders involved. CSOFT Health Sciences’ global network of in-country linguists and clinical trial translation specialists enable clear, cost-effective, and consistent translations for all document types for phase 0-IV of the clinical process and remote clinical trials.

Learn more about our translation services for multilingual clinical trials.

Drug Product Labeling Translations

Drug product labels, also known as prescription labels, contain information about the pharmaceutical product’s manufacturer, directions for use, dosage, expiration date, lot number or batch number, timing, and method of administration. With the implementation of EU MDR, as well as other changes in the global regulatory landscape particularly with concern to e-labelling or instruction for use (IFU), accurate pharmaceuticals translations are critical in complying with local regulatory laws.

As the demand for pharmaceutical products grows worldwide, drug product labeling translations become vital as more and more clinical trials are being conducted in countries where English is not the primary language. Failure to provide accurate translations of drug study labels can lead to regulatory delays, loss of market access, wasted resources and money, as well as potentially endanger patient lives. CSOFT Health Sciences provides highly accurate and timely translations for drug study labels to ensure that life science companies maintain regulatory compliance and receive the best ROI.

Learn more about our drug product labelling services.

Pharmaceuticals products

Multilingual eLearning & Training Solutions

Life science companies expanding into global markets require e-Learning and training translations for not only potential and current clients, but also their own employees. The pharmaceutical industry requires expert eLearning and training materials to keep staff up to date with prescribing practices for the latest drug breakthroughs, as well as provide guidance for administering drug therapies to patients. With an increasing number of clinical trials being conducted overseas, providing culturally appropriate and accurate training materials to educate pharmaceutical staff as well as patients is critical for improving patients’ lives globally.

CSOFT Health Sciences provides eLearning medical translation and localization solutions to facilitate continuing medical education (CME) for healthcare professionals, and to effectively educate patients. In addition, CSOFT offers video translation services such as multilingual video voiceover, subtitling, and dubbing.

Learn more about our eLearning and training solutions.

Pharmaceuticals require expert translations

Regulation Translations and Legislation Translations

Regulation and legislation translations are implemented to ensure compliance and to provide safe and high-quality services to clients. Compliance has become more complex due to globalization, heightened expectations, innovation, and ever-evolving customer needs. Whether you represent a pharmaceutical company, medical device company, the US Food and Drug Administration (FDA), the International Organization for Standardization (ISO), or the European Union (EU), regulations and legislation ensure safety of product use for drugs, vaccines, biological medical products, medical devices, and radiation-emitting products. As companies and organizations continue to release products into new markets and reach customers throughout the world, keeping up with new regulations and legislation is necessary to meet customer needs. CSOFT Health Sciences provides accurate translations for all types of regulation and legislation related scenarios. With a global network of in-country linguists and the expertise to translate between over 250 languages, we can help localize your regulations and legislation needs.

Learn more about our regulation and legislation translations.

Pharmaceutical Product Guidance Translations

As the pharmaceutical industry continues to expand globally, there remains a high demand for pharmaceutical product guidance translations to help companies expand into new markets and remain in compliance with international pharmaceutical regulations. The global pharmaceutical industry is heavily regulated and meeting the safety requirements and documentation requirements for the approval of new products is critical to success in overseas competitive markets. CSOFT Health Sciences specializes in delivering accurate and timely localization solutions for the pharmaceutical industry in 250+ languages.

Learn more about our pharmaceutical product guidance translations.

Intellectual Property Translations for Pharmaceuticals

As the pharmaceutical industry continues to expand globally, there remains a high demand for pharmaceutical product guidance translations to help companies expand into new markets and remain in compliance with international pharmaceutical regulations. The global pharmaceutical industry is heavily regulated and meeting the safety requirements and documentation requirements for the approval of new products is critical to success in overseas competitive markets. CSOFT Health Sciences specializes in delivering accurate and timely localization solutions for the pharmaceutical industry in 250+ languages.

Learn more about our pharmaceutical product guidance translations.

Quality Assurance

Through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.

Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in  ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.

Learn more about our quality assurance process.

High Quality Academic Translations
ISO-certified Academic Translations

Data Security

As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.

Learn more about how CSOFT protects companies’ data.

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