From clinical protocols to ICSR narratives — audit-ready documentation managed by experienced medical PMs. Trusted across the clinical trial and drug safety ecosystem.
On the Market
CEE & Beyond
Certified
Hosted in Germany
30+ languages spanning Central & Eastern Europe, the Baltics, the Balkans, and the Caucasus.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 throughout the clinical and product lifecycle.
Designed for accuracy, traceability, and audit-readiness.
Scope, timelines & risk assessment
Qualified medical linguists
Accuracy & terminology review
Verified by a separate
QC team
Secure file handoff
Amendments & updates
Client relationships protected by strict NDAs
We work with life science organizations that need specialized language coverage for CEE, Baltic, Balkan, and Eastern European markets — across the full clinical and regulatory lifecycle.
Managing multilingual clinical documentation across trial sites means version control, terminology consistency, and translation on the critical path of every activation, amendment, and submission.
We handle protocols, amendments, investigator brochures, ICFs, and patient materials — one vendor, one PM, with amendment tracking and consistent terminology maintained across all trial phases.
PV operations run on fixed reporting windows, zero-error terminology, and full audit readiness — a translation vendor that falls short on any of these creates direct regulatory risk.
We translate ICSR narratives, source documents, DHPC letters, PSUR/PBRER, and risk minimization materials — structured around 15-day and 7-day windows, with medical terminology consistency and documented workflows ready for authority audit.
eCOA platforms run multiple studies simultaneously — each one needs localized strings tested inside the application, PRO instruments translated through a documented validation process, and the same terminology standard applied across every study and language.
We handle string translation, in-application linguistic QA, and full forward/back translation with reconciliation — same workflow, same terminology standard, fully documented across every study on your platform.
Pharmaceutical products generate translation needs across clinical, regulatory, and pharmacovigilance functions simultaneously — terminology drift between functions and inconsistent amendment tracking across country versions create regulatory risk at every stage.
We cover the full document lifecycle — clinical trial documents, regulatory submissions, SmPCs, PILs, labeling updates, and pharmacovigilance materials — single vendor, terminology databases and translation memories updated through every amendment cycle.
First multi-country trials start with no translation memory, no approved terminology, and no established process — and inconsistencies introduced early carry through every document, every language, and every amendment that follows.
We handle protocols, ICFs, and site activation materials — building your terminology and translation memory databases from day one to keep all documents, languages, and amendment cycles consistent from first submission onward.
Specialized linguistic services for regulated life science environments.
Built for the compliance, urgency, and documentation standards of regulated life science work.
Our quality management system is ISO 9001-certified. Translation workflows are aligned with ISO 17100 requirements — separate translation, editing, and proofreading stages — with full amendment and version tracking across every revision.
A dedicated QC team, operating separately from translation and editing, performs an independent review of every project before delivery.
Every linguist is vetted for medical/life-science education and hands-on domain experience — documentation and blind CVs available on request for your own vendor audits.
Clinical PMs with 7+ years managing multilingual clinical trial documentation across phases and therapeutic areas — a single point of contact for every project.
Structured to support short-notice and time-critical work, including urgent safety and compliance deadlines.
Translation memory and terminology databases carry accuracy forward across projects, while automated linguistic QA checks catch terminology and numerical inconsistencies.
Information security management independently certified.
Hosted in Germany. No public cloud — no AWS, Azure, or Google Cloud.
Translation memory on private, on-premise infrastructure only.
Legally enforceable NDAs for all personnel on every project.
Schedules alignable with client SOPs on request.
Tell us your languages, document types, and timelines — we'll respond within one business day.