Gaining marketing authorization for pharmaceutical products in international markets requires submitting a Risk Management Plan (RMP) to regulatory authorities, making RMP translations essential to for life science companies working overseas to meet the growing global demand for new therapies. RMPs 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 pharmaceuticalvdossiers documents, including drug product labeling translations, instructions for use (IFU) translations, package information leaflets (PILs) translations, and summary of product characteristics (SmPC) translations.
Learn more about our full-coverage dossier translations.
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.
Learn more about our pharmacovigilance translations.
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:
- Biotech Regulatory Translations
- Pharmaceutical Regulatory Translations
- Medical Device Regulatory Translations
- Chemical Regulatory Translations
- Public Health Regulatory Translations
- Hospital Regulatory Translations
Learn more about our expert regulatory translations for the life sciences sector.
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.