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Pharmaceutical Product Guidance Translations

CSOFT Health Sciences specializes in pharmaceutical product guidance translations to cover production, labeling, and manufacturing for new lifesaving drugs and therapies

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Home 9 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 comply with domestic and international pharmaceutical regulations. Product-specific guidance is published by the US Food and Drug Administration (FDA). It describes the Agency’s expectations and current thinking on safely and effectively developing new pharmaceutical products. Furthermore, FDA guidance facilitates new pharmaceutical products’ availability and enables companies to generate evidence and data needed to develop their latest products. Since the global pharmaceuticals industry is heavily regulated and meeting the safety and documentation requirements to approve new products is critical to success in overseas competitive markets, companies must understand and follow the FDA-issued guidance. With expertise in regulatory and pharmaceutical translations, CSOFT Health Sciences offers high-quality pharmaceutical product guidance translations to help companies and professionals succeed in the global pharmaceutical industry.

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 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 pharmaceutical industry is growing rapidly. Companies looking to reach new customers and keep up with this demand must ensure all of their clinical trial documentation, regulatory documentation, and medico-marketing content are available across various 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 comply 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.

 

Pharmacovigilance Translations

Pharmacovigilance focuses on monitoring, reporting, and preventing adverse drug reactions (ADR). This branch of pharmacology also includes safety reporting for severe adverse reactions (SAR), serious adverse events (SAE), and suspected unexpected severe adverse reactions (SUSAR). Pharmacovigilance is central to regulatory compliance in clinical trials and the introduction of new drugs into the market. CSOFT Health Sciences offers localization solutions for pharmacovigilance documents and drug safety reporting.

Learn more about our pharmacovigilance translations.

Pharmaceuticals require expert translations

Regulation and Legislation Translations

Regulation and legislation translations are implemented to ensure compliance and provide safe and high-quality client services. Compliance has become more complex due to globalization, heightened expectations, innovation, and ever-evolving customer needs. Whether you are a pharmaceutical company, a medical device company, the US Food and Drug Administration (FDA), the International Organization for Standardization (ISO), or the European Union (EU), regulations and legislations ensure the safety of product use such as 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 regulations and legislation 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.

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.

Learn more about our quality assurance process.

High Quality Academic Translations

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.

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