From clinical protocols to ICSR narratives — audit-ready documentation managed by experienced medical PMs. Trusted across the clinical trial and drug safety ecosystem.
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Certified
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25+ languages across Central and Eastern Europe, the Baltics, the Balkans, and the Caucasus,
Central Asia, and Türkiye.
Same TEP workflow, same QA standard across every language and every project.
Need a combination not listed here? We support additional languages through our partner network — ask us.
Expert linguistic support for regulated medical content across clinical development, regulatory approval, and product lifecycle.
Designed for accuracy, traceability, and audit-readiness.
Scope, requirements & risk assessment
By qualified medical linguists
Accuracy, terminology & consistency review
Independent verification before delivery
Final completeness check & secure delivery
Amendments, updates & version alignment
Client confidentiality protected by strict NDAs
We support life sciences organizations that need specialized language coverage across Central and Eastern Europe, the Baltics, the Balkans, the Caucasus, Central Asia, and Türkiye — throughout clinical development, regulatory activities, and the product lifecycle.
Multilingual clinical documentation across trial sites requires careful version alignment, consistent terminology, and timely translation during study start-up, amendments, and submissions.
We support protocols, amendments, investigator’s brochures, ICFs, and patient materials through one coordinated workflow, helping teams track affected translations and maintain consistent terminology across documents and languages.
Pharmacovigilance operations depend on fixed reporting timelines, precise safety terminology, and complete documentation. Translation delays or inconsistencies can create direct compliance and regulatory risk.
We translate ICSR narratives, source documents, DHPCs, PSURs, PBRERs, and risk-minimisation materials using controlled terminology, documented workflows, and timelines aligned with case-reporting requirements.
eCOA platforms often support multiple studies simultaneously, each requiring localized strings tested in the application, PRO instruments translated through a documented validation process, and consistent terminology across studies and languages.
We support string translation, in-application linguistic QA, and forward and back translation with reconciliation through a consistent, fully documented workflow.
Pharmaceutical products generate translation needs across clinical, regulatory, and pharmacovigilance functions. Terminology drift between teams and inconsistent amendment tracking across country versions can create rework, delays, and regulatory risk.
We support clinical trial documents, regulatory submission materials, SmPCs, PILs, labelling updates, and pharmacovigilance content through one coordinated workflow, with terminology databases and translation memories updated throughout amendment cycles.
Early multi-country trials may begin without established translation memories, approved terminology, or a consistent multilingual process. Inconsistencies introduced at this stage can carry across later documents, languages, and amendments.
We support protocols, ICFs, and site start-up materials while building terminology resources and translation memories from the outset, helping maintain consistency across documents, languages, and amendment cycles.
Specialized linguistic support for regulated life sciences content and workflows.
Built to meet the quality, security, urgency, and documentation requirements of regulated life sciences work.
Our quality management system is ISO 9001 certified, and our translation workflows incorporate relevant ISO 17100 principles, including qualified linguists, independent revision, and documented quality controls.
A separate reviewer performs final quality checks before delivery, independently of the translation and editing stages.
Linguists are selected based on relevant qualifications, medical or life sciences expertise, and proven subject-matter experience. Anonymized CVs and qualification records are available for client review on request.
Experienced project managers coordinate multilingual clinical documentation across study phases, therapeutic areas, and languages, serving as the primary point of contact throughout each project.
Responsive planning and project coordination help us accommodate short-notice requests across supported language combinations.
Translation memories and terminology databases help preserve approved wording across projects, while automated linguistic QA checks flag terminology, numerical, formatting, and consistency issues.
Independently certified information security management system.
Production systems and client project data are hosted on dedicated servers in Germany.
CAT tools and linguistic assets are maintained within access-restricted production systems.
Confidentiality agreements apply to all personnel with access to client content.
Retention and deletion schedules aligned with client requirements on request.
Share your languages, document types, and required timelines, and we'll respond within one business day.