Professional life science translation services

Life sciences operate in a high-stakes, strictly regulated environment where every word carries clinical and legal implications. Whether submitting dossiers to the MHRA, coordinating a multi-country clinical trial with the EMA as Reference Member State, or scaling a medical device across Europe, accurate translation determines approval timelines, market access, and patient safety. Misinterpretations in IFUs, labelling, or pharmacovigilance documentation can lead to delays, corrective actions, or recalls—risks no organisation can afford.

Regulatory bodies demand clarity, consistency, and traceability. In the UK, MHRA guidelines and NICE terminology must be respected; across Europe, MDR/IVDR requirements dictate exact phrasing for safety and performance. Clinical study documents—from informed consent forms and investigator brochures to patient diaries—must be translated with sensitivity, readability, and cultural appropriateness while preserving scientific precision. For pharmacovigilance, signal detection and case safety reports depend on reliable translation of adverse events using standardised terminologies.

Market expansion further raises the stakes. Launching across the UK, EU, US, and APAC requires harmonised terminology across SmPC/PI, PILs, device labelling, eIFUs, promotional materials, training content, and digital interfaces. Consistency across this ecosystem supports brand credibility, ensures healthcare professional trust, and reduces post-market risk. Meanwhile, multilingual manufacturing, quality, and supplier documentation must align with SOPs, CAPA records, and change control logs to protect audit readiness.

Effective life science translation therefore balances scientific accuracy with regulatory compliance and patient-focused clarity. It demands subject-matter expertise, controlled vocabulary usage (e.g., MedDRA, SNOMED CT, EDQM), and structured workflows that deliver verifiable quality. By investing in specialised translation, organisations accelerate approvals, reduce compliance risk, and create a robust foundation for sustainable global growth.

Kings of Translation pairs sector-trained linguists with medical reviewers and quality managers to provide regulatory-grade translations for pharma, biotech, and medical devices. Our teams work exclusively in their areas of expertise—oncology, rare diseases, vaccines, cell and gene therapies, diagnostics, surgical devices—ensuring each project is handled by translators familiar with the science, clinical context, and applicable regulations.

Our quality system is aligned with ISO 17100 and ISO 9001 practices, delivering a rigorous multi-step process: translation by a subject-matter expert, independent medical review, QC checks, and final in-context validation. For high-risk content, we add back translation and reconciliation, linguistic validation for patient-facing instruments, and readability testing to meet MHRA/NICE expectations. We maintain controlled terminology and style guides to protect brand consistency across indications and markets.

We understand compliance across jurisdictions and frameworks: UK MHRA, EU MDR/IVDR, EMA guidance, FDA CFR, Health Canada, PMDA (Japan), and NMPA (China). Our processes incorporate data privacy safeguards aligned with UK GDPR, and where applicable, HIPAA for US studies handling protected health information. Confidentiality is embedded via NDAs, secure environments, and strict access controls for clinical data and eTMF records.

From regulatory dossiers (eCTD modules), SmPC/PI, and labelling to clinical trial documentation (protocols, IBs, ICFs, diaries), pharmacovigilance submissions, PMS/PMCF reports, and CAPA/QMS documentation, we deliver precise, audit-ready translations. With global acceptance and a 98% customer return rate, clients rely on us to reduce risk, keep timelines on track, and help teams communicate clearly—internally and with regulators worldwide.

We integrate with the tools life science teams already use. Connect your Veeva Vault, MasterControl, or other QMS/eTMF platforms through secure API, SFTP, or portal-based workflows to accelerate submissions and audits. For clinical operations, we support CTMS and EDC systems (e.g., Medidata, Oracle) as well as eCOA/ePRO vendors, ensuring the latest versions and amendments are translated consistently and routed through appropriate approvals.

Translation memory and terminology management underpin scalability and consistency across large programmes. We build language assets for each study or product family—glossaries, style guides, approved translations—so repeated content is leveraged while maintaining context-specific accuracy. This reduces cost per update, enables rapid turnarounds for safety communications, and protects labelling and IFU consistency across SKUs and regions.

Security is engineered end-to-end. We apply role-based access, encryption in transit and at rest, secure file transfer, and configurable retention policies. Audit trails record every step of the process, supporting inspections and CAPA evidence. For sensitive datasets, we offer anonymisation/pseudonymisation workflows and restricted environments. Our teams follow documented SOPs and undergo regular data protection and compliance training aligned with UK GDPR.

At scale, our project managers orchestrate multi-language rollouts spanning 120+ languages with parallel production streams and round-the-clock capacity. Automated notifications, version control, and structured QA gates ensure the right stakeholders review the right content at the right time. The result: predictable timelines, fewer surprises, and a transparent delivery model that grows with your pipeline.