When patient safety is on the line, every word matters. Our streamlined process translates your critical pharmacovigilance documents with unmatched accuracy, speed, and compliance, so you can focus on what matters most—protecting patient safety worldwide.
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Deliver more reliable translations for all critical safety documents quickly. We make sure your documentation is precise and ready for submission.
Leveraging AI for fast, cost-effective translations allows you to meet multilingual reporting requirements while reducing overall cycle times by 40%. A global team of on-demand translation experts provides an extra layer of quality assurance. For additional information on how to streamline the process, visit our Pharmacovigilance Solutions page.
Accurate translations of pharmacovigilance documents are essential for maintaining regulatory adherence and ensuring safety. With expertise in translating key documents across the product lifecycle, from Pharmacovigilance System Master File (PSMF) documents through to commercialization communications. Our automated translations meet the specific requirements of regulatory agencies such as the FDA, EMA, and others. This system also includes a case triage process for timely categorization and prioritization of adverse event reports.
Popular pharmacovigilance and drug safety translation projects include:
Database Reporting and Case Management
Our dual-review process involves advanced neural machine learning paired with linguistic review by life sciences specialists. Dual-review ensures translations are accurate and meet regulatory compliance and industry standards.
Your data will be secure as our team adheres to the highest industry standards. In addition to encrypted data handling, automated PII redaction is utilized to ensure that any personal or clinical data is carefully redacted in compliance with privacy laws (such as GDPR or HIPAA).
Yes, our global team of life sciences linguists leverages TransPerfect's proprietary translation management system to handle enterprise volumes with tight deadlines. Our infrastructure is designed to uphold the highest standards of quality, accuracy, and regulatory compliance, regardless of project size and timeline.
Yes, we provide comprehensive translation services for all phases of the product lifecycle, including post-market surveillance. All translations will be in compliance with global regulations for adverse event reporting, periodic safety update reports (PSURs), or risk management documentation.
Our translation services seamlessly integrate into your existing systems, including eTMF (electronic trial master files) and ePRO (electronic patient-reported outcome) systems. Our technical team works closely with yours for a smooth integration, reducing workflow disruptions and maximizing efficiency.
We provide revision support for any updates or changes to your documents, whether it’s a regulatory change or a modification to your safety reporting requirements.
Discover how TransPerfect Life Sciences ensures compliance with regulatory standards, improves global reporting accuracy, and simplifies the translation of documents for pharmacovigilance and drug safety.
