Pharmaceutical translation for regulatory submissions in the EU

Translation that meets EU regulatory deadlines

We plan translation backwards from your submission date. Regulation (EU) 536/2014 (CTR) sets a 10-day window to validate a clinical trial application. Part I and Part II assessment each run 45 days, extendable by up to 31 days.

• PSURs follow EURD-list deadlines under GVP Module VII.
• eCTD sequences must land at procedure milestones.
• A late translation can push a CTA past validation day, miss a sequence and trigger clock-stops.

Translation planning starts from these clocks. Your timeline is anchored to your submission calendar.

The documents behind a marketing authorisation and beyond

SmPC and PIL text follows EMA QRD templates across 25+ EU languages. Every language version stays in step through the QRD lifecycle.

• Labelling and artwork follow the same QRD structure.
• Windsor Framework rules apply to UK(NI) packs.
• Device labels, IFUs and implant cards must meet MDR 2017/745 Annex I §23.
• Each Member State decides the labelling languages for devices.

We translate the full set, from SmPC to implant card.

Clinical trial translation: CTIS Part I and Part II

CTIS splits a clinical trial application into Part I and Part II. Each part follows its own assessment route.

• Part I: protocol, investigator's brochure and IMPD. The Reporting Member State assesses these within EU-mandated timelines.
• Part II: subject information sheet, informed consent form (ICF) and site documents, per Member State and ethics rules.
• Lay summary of results must be understandable to laypersons. It is posted to CTIS under strict transparency timelines.
• In Ireland, IMP labelling is in English; other languages are allowed grouped.

We translate the full CTR Annex I document set: protocol, IB, IMPD, ICF, subject information, CSR and lay summary.

How we work: certified process, insider fluency

Our process has been ISO 9001, ISO 17100 and ISO 18587 certified since 2021. A qualified linguist signs off on every translation, and a second qualified translator revises every file.

• We maintain per-product terminology bases and translation memory. Dosing and indication wording stays consistent across languages.
• Machine output that no linguist has reviewed sits outside the certified process. Governed machine-translation post-editing with human revision is available where you direct it.
• Delivery is TMS-compatible (XLIFF and TMX). Export and import round-trips move content into controlled document systems such as Veeva Vault, with records per validated deliverable.

Why buyers choose a Dublin-based team

Our team works from Dublin, inside Irish, EU and UK regulatory practice. Your submission calendar sets the plan.

• We work with HPRA CTR guidance, national language rules, EURD lists and submission calendars.
• A named project manager answers directly, and the team works the CTIS, eCTD and Veeva-aware document set at submission pace.
• Pre-submission dossiers are handled under the ISO 17100 data-protection requirement.
• We sign NDAs and DPAs, and apply CTIS CCI-redaction awareness from intake.
• Transfer is secure, processing stays EU-only, with an audit trail.

Process and timeline

We scope, align, translate, revise and deliver in a defined order. Your statutory clocks anchor every step.

1. Scope the document set and language matrix per country.
2. Align terminology per product and market, QRD and MedDRA-aware.
3. Translate, then revise with a second qualified translator.
4. Deliver validated files with versioned records.

The timeline is anchored to your statutory clocks. We work backwards from your submission date.