CSOFT’s 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), clinical trial documentation, and pharmacovigilance – involve significant document volumes that require high levels of accuracy 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 patient death. CSOFT understands these concerns, and provides pharmaceutical 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 for pharmaceutical companies.
Pharmaceuticals in Multilingual Clinical Trials
Clinical trials are an essential element of the drug development process. As the demand for pharmaceutical drugs increases overseas, more and more clinical trials are conducted in countries where English is not the dominant language. To satisfy regulatory compliance and meet recruitment targets, using high-quality and accurately translated and localized clinical trial documentation and patient recruitment material is essential for successful clinical trials. CSOFT provides culturally appropriate and accurate translation services for pharmaceutical companies for all documents, including phase 0-IV clinical trial documentation and patient recruitment material.
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Drug Product Labelling
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 upcoming implementation of the EU MDR, as well as other changes in the global regulatory landscape particularly with concern to e-labelling or instruction for use (IFU), accurate pharma translations are critical in complying with local regulatory laws.
As the demand for pharmaceutical products grows worldwide, 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 provides highly accurate and timely translations for drug study labels to ensure that life science companies maintain regulatory compliance and receive the best ROI.
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Pharmacovigilance is a branch of pharmacology that focuses on monitoring, analyzing, reporting, and preventing adverse drug reactions (ADRs). As the global pharmaceutical market shifts overseas, submitting extremely accurate translations of common pharmacovigilance documents like adverse event (AE) and individual case study reports (ICSR) to regulatory agencies on time is critical for protecting consumers worldwide. With a global network of subject matter experts and over 10,000 in-country native linguists, CSOFT offers highly-accurate and timely multilingual pharma translation solutions for a wide variety of pharmacovigilance needs in 250+ languages, from DSURS and discharge reports to CIOMs forms and clinical trial documents.
Learn more about our CSOFT’s pharmacovigilance translation services.
Multilingual eLearning & Training Solutions
The pharmaceutical industry requires expert eLearning and training materials to keep staff up to date with 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 provides eLearning translation and localization solutions to facilitate continuing education 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 e-Learning and training solutions for pharmaceutical companies.
Regulation 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 are a pharmaceutical company, medical device company, US Food and Drug Administration (FDA), International Organization for Standardization (ISO), or European Union (EU), regulations and legislations ensure safety of product use such as 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 regulations and legislations is necessary to meet customer needs. CSOFT Health Sciences provides accurate translations for all types of regulations and legislations. With a global network of in-country linguists and expertise to translate over 250 languages, we can help localize your regulations and legislation needs.
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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.
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Intellectual Property Translations for Pharmaceuticals
For pharma companies creating groundbreaking treatments and drug therapies, protecting its intellectual property (IP) in the target market as well as the market it was invented in is vital to protecting and advancing technology and innovation through creative thinking.
CSOFT provides highly accurate IP translation services for life science companies across 250 languages. Utilizing our advanced language technology, combined with our extensive network of over 10,000 in-country professional linguists and subject matter experts, we have the experience and resources to effectively translate IP documents with ease, including patents, trademarks, and copyrights.
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Pharmaceutical Regulatory Translations
The global pharmaceuticals industry is one of the most heavily regulated in the world, with standards for safety in place and strict approval processes to bring new drug to international markets. During the drug development process, ensuring that all documentation is in compliance with these standards and meets the language requirements will prove necessary for companies working in this space. CSOFT Health Sciences provides expert regulatory translations for anyone in the pharmaceuticals industry, and we provide localization support in additional areas including clinical trial translations, medico-marketing translations, drug safety report translations, and more.
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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.
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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.
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