Pharmaceutical Product Guidance Translations
CSOFT Health Sciences specializes in pharmaceutical product guidance translations to cover the production, labeling, and manufacturing of potentially lifesaving drugs and therapies.
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 both domestic and international pharmaceutical regulations. Product-specific guidance is published by the US Food and Drug Administration (FDA) and describe the Agency’s expectations and current thinking on how to safely and effectively develop new pharmaceutical products. Furthermore, FDA guidance is used to facilitate the availability of new pharmaceutical products and to enable companies to generate evidence and data needed to develop their new products. Since the global pharmaceuticals industry is heavily regulated and meeting the safety and documentation requirements for the approval of new products is critical to success in overseas competitive markets, companies must be able to understand and follow the FDA-issued guidance. With expertise in regulatory translations and pharmaceutical translations, CSOFT Health Sciences offers high-quality pharmaceutical product guidance translations to help companies and professionals succeed in the global pharmaceuticalindustry.
In addition to our expertise in pharmaceutical regulatory translations, we provide localization solutions for other FDA-issued guidance, including medical software system guidance translations.
Learn more about our medical software system guidance translations.
End-to-End Pharmaceutical Translations
From pre-development research into new therapies, all the way to post-production and aftermarket surveillance, each stage of the drug development process is heavily regulated and requires a wide range of documentation to have products successfully brought to market. The global pharmaceuticals industry is growing at a rapid pace and companies looking to reach new customers and keep up with this demand need to ensure all of their clinical trial documentation, regulatory documentation, and medico-marketing content are available across a range of languages. With a global network of 10,000+ in-country linguists and subject matter experts, CSOFT Health Sciences specializes in pharmaceutical translations, offering a wide range of localization solutions for all stages of the drug development process, including:
Drug Product Labeling Translations
Drug product labels contain important information such as instructions for use, dosage information, administration methods, and more. Drug product labels are heavily regulated in the pharmaceutical industry and must be in compliance with product guidance information. As the demand for pharmaceutical products continues to expand globally, drug product labels need to be translated into different languages and must be in compliance with global regulations. CSOFT Health Sciences offers highly accurate and consistent translations for drug product labels across 250+ languages, including translations of summary of product characteristics (SmPCs) for EU markets.
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Pharmacovigilance focuses on the monitoring, reporting, and preventing of adverse drug reactions (ADR). This branch of pharmacology also includes safety reporting for serious adverse reactions (SAR), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSAR). Pharmacovigilance is a central part of regulatory compliance in clinical trials and bringing new drugs onto markets. CSOFT Health Sciences offers a full range of localization solutions for pharmacovigilance documents and drug safety reporting.
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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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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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