Pharmaceutical Translation Services

Pharmaceutical product information is the most template-governed text we translate. European submissions follow the QRD template: fixed headings, fixed standard statements, and per-language conventions that are published and expected verbatim. A translation that paraphrases a standard statement, however elegantly, comes back from linguistic review as an error.

How we handle product information

Our pharmaceutical linguists work from the current template texts in their language, so standard statements land as the template requires and only the product-specific content is genuinely translated. The SmPC, PIL and labelling for a product are treated as one linked set: a change in the SmPC's clinical particulars flows through to the PIL's lay wording and the carton text consistently, in every language, because all three run on one memory and one glossary per product.

Readability of the package leaflet

The PIL is a lay document by law, and its readability is tested with real users. Translations have to preserve that lay register: short sentences, everyday words for anatomy and symptoms, and instructions a worried patient can follow at home. Our second-linguist review on PILs is a comprehension review, not just an accuracy check.

Artwork, Braille and mock-ups

Product information ends its life as artwork: cartons, blister foils and leaflets with tight type areas and, for cartons, Braille. Our multilingual DTP studio returns print-ready mock-ups with translated text flowed, RTL languages set correctly and text expansion handled, so your artwork house receives final files.

Each route to market has a distinct translation profile, and planning for it early is the difference between a calm submission and a very expensive fortnight.

The centralised procedure

A centralised marketing authorisation covers the whole EU at once, which means product information in every official EU language plus Norwegian and Icelandic, produced against a compressed linguistic-review timetable that begins the moment the CHMP opinion lands. The only way that fortnight goes smoothly is preparation: templates staged per language, product glossary agreed, and a linguist team booked before opinion day. That is exactly how we run it, so the full language set arrives inside the window with capacity held in reserve for member state comments.

Mutual recognition and decentralised procedures

MRP and DCP produce national translations for the concerned member states at the end of the procedure, on their own clock. The volume is smaller than centralised but the consistency requirement is identical, and the national comments phase rewards translations that were right first time.

UK national route

MHRA submissions run in English, but UK holders of European portfolios still carry the full multilingual estate, and products in-licensed from abroad arrive with dossiers, batch documentation and correspondence in their source languages. We translate submission-supporting documents in both directions, including the notarised and certified formats that legalisation sometimes requires.

Variations, renewals and the long tail

An authorisation is never finished. Safety variations, new indications and renewals each touch the product information, and every touched language must move in step. Because each product runs on versioned memory, a variation is translated as a delta: what changed is retranslated, what did not stays verbatim, and divergence between language versions cannot silently creep in.

Safety translation is the part of pharmaceutical work where the clock is regulatory. Expedited individual case reports run on day counts measured from first receipt, and a case that arrives in Portuguese or Japanese still has to be assessed, processed and reported inside the same window.

What we translate for PV teams

• Individual case safety reports: source narratives, hospital records, reporter correspondence, translated for case processing with medical terminology handled by medically qualified linguists
• Literature surveillance: articles from local and regional journals flagged by your screening, translated or summarised so assessment can happen quickly
• Periodic reports: PSURs, PBRERs, DSURs and addenda, plus responses to assessor questions
• Risk minimisation materials: educational materials for prescribers and patients, translated with the same register care as the PIL
• Safety communications: direct healthcare professional communications produced in parallel across every affected market

Built for the clock

PV translation runs through our urgent lane when the case demands it: same-day turnaround on case narratives, parallel processing across languages for DHPCs, and weekend availability by arrangement for standing PV clients. Terminology follows recognised medical dictionary conventions so translated cases drop cleanly into your safety database rather than needing recoding.

Behind every product sits a manufacturing and quality estate that becomes multilingual the moment your supply chain crosses a border: a contract manufacturer in another country, an API supplier audited in their own language, an inspection conducted through translated records.

The documents

• Standard operating procedures exchanged between sites, where instruction wording is a compliance matter
• Batch manufacturing and packaging records, including handwritten entries, for release, deviation and complaint investigations
• Validation and qualification protocols and reports
• Deviation, OOS and CAPA documentation moving between quality units in different countries
• Audit reports and responses for supplier qualification and authority inspections
• Quality and technical agreements, handled with our legal translation practice

Why specialists matter here

GMP text is dense with fixed terminology where near-synonyms are not interchangeable: a deviation is not an incident, qualification is not validation, and an SOP that drifts in translation produces two sites doing subtly different things while believing they comply with the same procedure. Our pharmaceutical linguists live in this vocabulary, and a per-client glossary keeps your site-to-site language exact. For inspection support, we translate requested records fast enough to keep pace with an authority on site, through the urgent lane where needed.

Beyond the regulated core, pharmaceutical companies produce a wide band of content that must stay factually consistent with the approved product information while speaking to entirely different audiences.

Promotional and medical content

Detail aids, brochures and campaign material are adapted rather than literally translated, because persuasive register does not survive word-for-word transfer, but every claim must remain exactly consistent with the approved SmPC in that market. Our marketing-capable linguists work with claim sheets: the promotional text may be recast per market, the claims may not. Medical information response letters, congress materials and training for field teams follow the same rule through our e-learning and marketing translation practices, all drawing on the product glossary.

Market access and HTA

Value dossiers, health economics summaries and payer materials mix clinical evidence with economic argument, and national HTA bodies each have their own expectations of format and language. We translate access documents with the clinical terminology anchored to the product glossary and the economic terminology reviewed by linguists with financial-document experience from our financial translation practice.

One partner, one record

The practical benefit of running regulated, safety and commercial content through one translation partner is the audit trail: one glossary, one memory, one version history per product, and one accountable project manager. When an auditor, assessor or brand reviewer asks why a term was rendered a certain way in a certain market, the answer exists in writing. Pricing is per word from £0.10 with automatic repetition discounts; the online quote prices individual documents instantly, and portfolio work runs under enterprise arrangements with volume rates, priority turnaround and consolidated invoicing.