医药产品指南翻译

CSOFT华也生命科学精通药品指南翻译,包括拯救生命的药物和疗法的研发、标签和生产。

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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:

A.I. Translations

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.

Learn more about our drug product labeling translations.

药物警戒翻译

药物警戒关注药物不良反应(ADR)的监测、报告和预防。这个药理学分支还包括严重不良反应(SAR)、严重不良事件(SAE)和可疑严重不良反应(SUSAR)的安全报告。药物警戒是临床试验和新药上市的监管合规的核心部分。CSOFT华也生命科学为药物警戒文件和药物安全报告提供全方位的本地化解决方案。

了解更多关于我们的药物警戒翻译。

Pharmaceuticals require expert translations

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.

Learn more about our regulation and legislation translations.

质量保证

高质量的翻译和本地化业务对政府机构极为重要 - 不准确的翻译不仅会导致时间、成本和精力的浪费,而且还会影响患者和消费者的生活。这就是为什么CSOFT华也生命科学致力于确保最高质量的翻译服务。为此,我们聘请至少有7年经验的本土语言学家,并且不断拓展我们的多领域主题专家网络。此外,我们通过语言验证回译术语管理不断完善本地化最佳实践,帮助政府机构、非政府组织、公共部门和国际组织接触不同文化背景的社区。

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质量保证
数据安全

数据安全

我们拥有完善的文档和完全可追溯的信息安全政策、检查表和质量记录。CSOFT华也生命科学了解数据安全对客户的重要性,我们将全力保障客户信息的机密安全。我们所有的数据和安全流程得到了ISO 17100:2015ISO13485:2016ISO 9001:2015质量管理体系的认证。同时,我们的操作流程与ISO 27001提供的最佳实践方式保持一致。

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