Gaining marketing authorization for pharmaceutical products in international markets requires submitting a Risk Management Plan (RMP) to regulatory authorities, and to meet the growing global demand for new therapies, Risk Management Plan (RMP) translations are essential to for life science companies working overseas. Risk Management Plans are submitted as part of a dossier for new pharmaceutical products and include crucial information on the product’s safety profile, efficacy, pharmacovigilance activities, and effectiveness of risk minimization measures which are set in place to protect patients. For any company developing new pharmaceutical products in the European Union (EU), Risk Management Plans are required by the European Medicines Agency (EMA) and are important for upholding the safety measures during post-market drug surveillance. CSOFT Health Sciences supports life science companies with high-quality Risk Management Plan translations to expedite the drug submission process and successfully bring new products to overseas markets.
In addition, CSOFT Health Sciences offers a full range of translations for pharmaceutical dossiers documents, including drug product labeling translations, instructions for use (IFU) translations, package information leaflets (PILs) translations, and summary of product characteristics (SmPC) translations.
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Ensuring Quality Pharmacovigilance Translations
The global pharmaceuticals market is a rapidly growing industry and to comply with international laws on pharmaceutical product safety, pharmacovigilance translations are a necessity for any company. Pharmacovigilance includes assessing, monitoring, analyzing, and preventing adverse drug reactions (ADRs). Post-market drug surveillance is crucial for upholding patient safety and ensuring that companies can successfully develop new drug therapies for international sale. CSOFT Health Sciences provides high-quality translations for all documents essential for accurately reporting ADRs, serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs) to regulatory agencies. Our global network of certified translators specialize in localization solutions for a variety of pharmacovigilance documents, including IRB correspondence translations, case report form (CRF) translations, FDA submission translations, and more.
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Regulatory Translations for the Life Sciences Industry
Life sciences companies face some of the strictest regulatory requirements of any industry and supporting these companies with high-quality translations for regulatory submissions is essential for success in global markets. Regulatory agencies including the European Medicines Agency (EMA), China’s National Medical Product Administration (NMPA), and the US Food and Drug Administration (FDA) have varying timelines, language requirements, and formatting standards for all types of documents needed for approving new products. CSOFT Health Sciences offers a full range of localization solutions for gaining regulatory approval in 250+ languages, including industry-specific translations like:
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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