Pharmaceuticals Translations
Unwavering commitment in the service of pharmaceuticals translation in 250+ languages to help bring new drugs to markets overseas.
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 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.
Pharmacovigilance Translations
Pharmacovigilance is a branch of pharmacology that focuses on monitoring, analyzing, reporting, and preventing adverse drug reactions (ADRs), making pharmacovigilance translations a crucial measure to ensuring proper documentation and resolution of such cases. As the global pharmaceutical market shifts overseas, submitting accurate translations of common pharmacovigilance documents like adverse event (AE) logs 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 Health Sciences offers highly accurate and timely multilingual pharmaceuticals translation solutions for a wide variety of pharmacovigilance needs in 250+ languages, from development safety update reports (DSURs) and discharge reports, to clinical trial documents.
Learn more about our pharmacovigilance translations.
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.
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.
Good Manufacturing Practice (GMP) Translations
Good manufacturing practice (GMP) is essential for quality production of pharmaceutical products and medical devices, making GMP translations necessary for meeting global manufacturing standards. GMP regulates medical products during production to protect patients from ineffective treatment and adverse events caused by contamination, incorrect labelling, and other manufacturing quality issues. Whether compliant with global practices or certified in a specific market like the U.S. FDA’s current good manufacturing practice (cGMP), GMP translations ensure that all manufacturing quality control measures, from audits and certification visits to everyday production, meet regulatory requirements in any country. CSOFT Health Sciences translates a wide range of GMP documents including site master files, validation master plans, and CAPA SOPs to ensure that your GMP translations are understandable across the manufacturing process.
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Quality Assurance
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And 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. Every step of the way, CSOFT has you covered.
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Data Security
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.