Pharmaceutical Translation Services
Safety reporting runs on regulatory clocks; product information runs on templates.
Last updated
- ISO 17100 certified and an ITI corporate member
- 260+ languages, native qualified linguists
- Certified translation from £35, transparent pricing
- Same-day return available on weekdays
- GDPR-compliant, files stored in the UK
What we translate for pharma teams
SmPC & PIL Translation
Product information translated with template discipline: standard statements land as the QRD template requires, per language
Labelling & Artwork
Carton and blister text, mock-ups returned print-ready with Braille positioning and RTL handled
Pharmacovigilance
ICSR narratives, literature surveillance, PSURs, DHPCs and risk minimisation materials on safety-report clocks
GMP & Quality Documents
SOPs, batch records, validation protocols, CAPAs and audit responses between sites and authorities
Regulatory Submissions
Dossier documents, assessor responses, variations and renewals kept in step across every language
Promotional & Medical Affairs
Detail aids, med info letters and market access dossiers, claims locked to the approved product information
SmPC, PIL and labelling discipline
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
- Template texts first: linguists work from the current template in their language, so standard statements land exactly as required and only product-specific content is genuinely translated
- One linked set: SmPC, PIL and labelling run on one memory and one glossary per product, so a change in the clinical particulars flows through to the lay wording and the carton text in every language
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.
Authorisation routes and translation
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.
Swipe sideways to see both columns.
| Route | The translation moment |
|---|---|
| Centralised (EMA) | Product information in every official EU language plus Norwegian and Icelandic, on a compressed timetable that starts the moment the CHMP opinion lands |
| MRP and DCP | National translations for each concerned member state at the end of the procedure; the comments phase rewards translations that were right first time |
| UK national (MHRA) | English submissions, with in-licensed dossiers, batch records and correspondence translated in both directions, including certified formats |
| Variations and renewals | Every touched language moves in step: deltas are retranslated against versioned memory, so language versions cannot silently diverge |
The centralised fortnight only goes smoothly with preparation: templates staged per language, the product glossary agreed, and a linguist team booked before opinion day. That is exactly how we run it, with capacity held in reserve for member state comments.
Pharmacovigilance never waits
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.
GMP, quality and manufacturing documentation
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.
Commercial, medical affairs and market access
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.
Our process, end to end
Product Glossary
Terminology base built per product: INN, indications, endpoint and safety vocabulary, locked at startup
Specialist Translation
Pharma-qualified linguist translates, working from current template texts where the document is templated
Second-Linguist Review
Independent accuracy review, plus lay comprehension review on patient-facing documents
Template & Consistency Check
Standard statements verified against the template, cross-document consistency verified across SmPC, PIL and labelling
Versioned Delivery
Delivery with updated memory so variations and renewals start from approved text in every language
Built for these teams
MA Holders & Pharma Companies
- Product information sets
- Variation and renewal deltas
- Assessor question responses
- Launch language programmes
- Promotional claim consistency
- Consolidated multilingual invoicing
Generics & Biosimilars
- Reference product alignment
- High-volume PIL programmes
- Fast national translations
- Artwork-ready delivery
- Portfolio-wide memory savings
- Competitive per-word rates
Consultancies & CDMOs
- Dossier document translation
- GMP and quality documents
- Inspection support translation
- Client-facing certificates
- White-label arrangements
- Flexible per-project engagement
What you get with Lingo Service
Template-Exact Product Information
SmPC, PIL and labelling translated against current template texts per language, so standard statements are never paraphrased
Safety-Clock Turnaround
Expedited case narratives and DHPCs same day, weekend availability by arrangement for standing PV clients
Pharma-Qualified Linguists
Translators with pharmacy, medical and life-science backgrounds, second-linguist review on every document
One Memory Per Product
Versioned memory and glossary per product keeps every language aligned through variations and renewals
260+ language pairs. These are our most-requested.
Frequently asked questions
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