Pharmaceutical Translations
We bring an unwavering commitment to the service of pharmaceutical translation to help bring new drugs to patients worldwide
The global pharmaceuticals sector, valued at over 1.4 trillion USD, is experiencing increased demand for pharmaceutical translations in domestic and foreign markets. This growth is driven by the demand for new drugs from international patients. This expansion fosters significant growth in drug development, encompassing multilingual clinical trials, drug production, and distribution, and forecasts increased profitability within the pharmaceutical sector.
However, as regions such as APAC, LATAM, and Europe become more accessible to the rest of the world, pharmaceutical companies must ensure that their pharmaceutical drugs are marketed with properly translated and localized 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 mitigates financial risks for companies due to regulatory non-compliance and safeguards patient well-being by ensuring the availability of life-saving treatments.
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 in 250+ languages for all stages of the medication lifecycle, from CTD/eCTD submission and phase 0-IV to clinical trial documentation, pharmacovigilance reports, and medico-marketing materials.
Medical Document Translation
Every phase of the medicine development lifecycle – from regulatory documents such as CTD/eCTD submissions and new drug applications (NDA) to clinical trial documentation and pharmacovigilance – involves substantial volumes requiring accurate medical document translations with swift turnaround times. Inaccurate or delayed translations could lead to regulatory compliance issues, causing costly delays in the drug development lifecycle and, worst case, adverse patient outcomes. Acknowledging these concerns, CSOFT Health Sciences delivers fast, high-quality translations for 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 constitute a significant investment in bringing pharmaceutical drugs, medical devices, and innovative treatments to market globally. Clinical trial translation solutions are essential to conducting trials overseas. For pharmaceutical companies entering foreign markets, precise translation is crucial to comply with local regulatory requirements. Inaccurate translation poses risks to regulatory viability and may jeopardize patient safety and drug efficacy, emphasizing the priority of precise, high-quality translation for all stakeholders. CSOFT Health Sciences’ global network of in-country linguists and clinical trial translation specialists enables 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, or prescription labels, contain crucial information such as manufacturer details, directions for use, dosage, expiration date, lot or batch number, timing, and administration method. With the EU MDR implementation and evolving global regulatory changes, especially in e-labeling or instruction for use (IFU), precise pharmaceutical translations are essential for compliance with local regulations. As global demand for pharmaceutical products rises, the importance of drug product labeling translations becomes evident, especially in countries where English is not the primary language for conducting clinical trials. Inaccurate translations of drug study labels can result in regulatory delays, loss of market access, resource wastage, financial implications, and potential harm to patients’ 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.
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Pharmacovigilance Translations
Pharmacovigilance is a branch of pharmacology that focuses on monitoring, analyzing, reporting, and preventing adverse drug reactions (ADRs), making pharmacovigilance translations crucial to ensuring proper documentation and resolution of such cases. As the global pharmaceutical market shifts overseas, submitting accurate translations of standard 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, from development safety update reports (DSURs) and discharge reports to clinical trial documents.
Learn more about our pharmacovigilance translations.
Multilingual eLearning & Training Solutions
Expanding life science companies need eLearning and training translations for both clients and employees in global markets. In the pharmaceutical industry, specialized eLearning materials are essential to keep staff informed about the latest drug breakthroughs and prescribing practices while also offering guidance on administering drug therapies. As the number of overseas clinical trials rises, delivering culturally appropriate and precise training materials becomes crucial for educating pharmaceutical staff and patients, ultimately enhancing global patient outcomes. CSOFT Health Sciences provides eLearning medical translation and localization solutions to facilitate continuing medical education (CME) for healthcare professionals and to educate patients effectively. 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 provide safe, high-quality client services. 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 the safety of product use for drugs, vaccines, biological, medical products, medical devices, and radiation-emitting products. As companies and organizations release products into new markets and reach customers worldwide, keeping up with new regulations and legislation is necessary to meet customer needs.
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Pharmaceutical Product Guidance Translations
As the pharmaceutical industry continues to expand globally, there is a high demand for translations of pharmaceutical product guidance to help companies expand into new markets and comply with international pharmaceutical regulations. The global pharmaceutical industry is heavily regulated, and meeting the safety and documentation requirements for approving new products is critical to success in overseas competitive markets.
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Intellectual Property Translations for Pharmaceuticals
Intellectual property (IP) translations for pharmaceuticals involve accurately translating documents related to patents, trademarks, copyrights, and other legal aspects within the pharmaceutical industry. This specialized translation service ensures that intellectual property rights, which are critical for protecting pharmaceutical innovations and products, are accurately communicated in different languages. Translating intellectual property documents is essential for pharmaceutical companies operating in global markets, enabling them to secure legal protection, navigate regulatory requirements, and safeguard their innovations worldwide.
Learn more about our intellectual property (IP) translations.
Pharmaceutical Marketing: A Multilingual and Multicultural Approach
Pharmaceutical marketing, also known as medico-marketing, encompasses the strategic promotion of pharmaceutical goods to varied audiences, including physicians, sales professionals, and other consumers like labs and hospitals. It aims to raise product and brand awareness, bolster brand image and equity, and facilitate product launches. In response to the growing demand for medicines in non-English speaking regions, pharmaceutical companies must provide marketing materials with impeccable accuracy and cultural suitability. CSOFT’s team of experienced writers, content creation specialists, and a vast network of in-country linguists and subject matter experts work to transcreate bespoke, high-quality medical information and patient-centered content. This improves health literacy and patient outcomes and generates trusted content for healthcare providers and brand-centric materials for sales professionals.
Good Manufacturing Practice (GMP) Translations
Good manufacturing practice (GMP) is essential for the 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 labeling, 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 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 at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. 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 the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.