Professional life science translation services

In life sciences, language is a safety and compliance requirement—not a formality. Regulatory submissions, clinical study documents, IFUs, and pharmacovigilance reports must use precise, validated terminology. A single mistranslation can delay approvals, undermine trials, or create risk for patients. That’s why organizations across pharma, biotech, and medtech rely on translators who understand GxP frameworks, risk management (ISO 14971), and labeling standards required by authorities in the United States and worldwide.

Whether you’re preparing an IND/NDA for the FDA, a dossier for the EMA, or device documentation for MHRA, PMDA, TGA, or Health Canada, the language must align with scientific conventions and jurisdiction-specific terminology. Patient-facing materials—ICFs, PI/SmPC, PILs, diaries, and questionnaires—require cultural adaptation to ensure comprehension and adherence across diverse populations without altering clinical intent.

Global market expansion also introduces complex documentation chains. RIM/eCTD modules, QMS procedures, CAPA records, and manufacturing batch documentation must be consistently translated to support audits and inspections. For medical devices, IFUs, labels, UDI details, packaging, and software UI/UX must read clearly, fit space constraints, and meet legibility rules across all target languages. Multilingual DTP isn’t cosmetic; it directly supports regulatory acceptance and user safety.

Kings of Translation helps you move confidently from lab to patient by combining industry-trained linguists with controlled terminology and layered QA. Our certified translations are recognized internationally, supporting submissions, post-market surveillance, and lifecycle updates as you scale products across geographies. With a 98% client return rate, we provide the continuity, responsiveness, and rigor life sciences require.

Every project is matched to a specialized linguist team with deep sector knowledge—therapeutic-area experts, device specialists, and medical writers experienced with clinical and regulatory content. We build project-specific termbases and style guides, aligning to your source documentation, investigator brochures, and historic submissions to ensure consistency across RIM or eCTD sequences.

Workflows follow ISO 17100–aligned best practices: native linguist translation, independent medical review, and final QA with terminology enforcement. For high-risk content (e.g., IFUs, device safety warnings, patient instructions), we offer back translation and reconciliation, cognitive debriefing for questionnaires, and in‑country medical review. Our HIPAA-aware processes and GDPR-aligned handling protect PHI and PII throughout the chain of custody.

We prepare submission-ready files for FDA, EMA, and other national competent authorities, including precise formatting, page limits, and module packaging. Our teams are fluent in device and drug standards such as ISO 13485 context, IEC 62366 usability insights, and GxP documentation controls. For pharmacovigilance and post-marketing communications, we translate ICSRs, PSUR/PBRER, RMPs, DSURs, and safety updates with expedited timelines.

Kings of Translation also supports multilingual DTP for labels, cartons, leaflets, and packaging inserts, preserving fit and legibility across languages with different character densities. We deliver regulatory-compliant PDFs and editable source files, ready for your labeling systems and document management platforms.

Our technology stack integrates with life science platforms so translation never becomes a bottleneck. We connect to Veeva Vault (RIM/QMS), MasterControl, Documentum, and leading CMS/DAM systems to automate content handoffs and version control. For regulatory teams, we prepare eCTD-ready outputs and support structured content reuse to keep sequences aligned across markets.

Translation memory and terminology management reduce cost and turnaround while protecting consistency across study phases, labeling cycles, and safety updates. Secure APIs enable automated job creation and status tracking from your systems, and our portal provides audit trails, change histories, and role-based access for sponsors, CROs, and device manufacturers.

For scale, we deploy domain-adapted machine translation with human-in-the-loop post-editing where appropriate, following your risk categorization—never for high-risk content unless explicitly authorized. Continuous localization pipelines support frequent labeling updates, UDI changes, and digital content refreshes without losing quality or compliance.

A dedicated project manager oversees resourcing, capacity planning, and KPI reporting, ensuring you have predictable timelines and clear SLAs. With 24/7 operations and global teams, we meet aggressive submission dates and phased market launches while maintaining scientific accuracy and regulatory readiness.