Pharmaceutical translation of regulatory and clinical documents
We translate marketing authorisation dossiers, summaries of product characteristics and package leaflets, clinical trial protocols and reports, informed consent forms, GMP certificates, analytical and batch records, and correspondence with regulators.
In pharmaceutical work what decides the outcome is not how the translation reads but whether it matches the source that governs that particular document. So for every document type we say up front what we are following: an approved wording, an established template, or the terminology of your own protocol. Office in Bratislava-Petržalka, all of Slovakia online.
- Regulatory dossiers, SmPCs and package leaflets, clinical protocols, GMP records
- Active substances are given by their international non-proprietary name, not the brand name
- Informed consent is written for the patient, not the specialist: plain language is the requirement
- Batch numbers, equipment codes and study identifiers are left untouched
Our guarantees
- 100% acceptance by authorities and institutions in Slovakia and abroad
- Guaranteed delivery by the agreed deadline
- 2-year guarantee on translation quality
- We process requests at weekends too – we reply every day 9:00–18:00
- Free quote in 15 minutes
- Confidentiality of your documents
What governs each document type
Pharmaceutical translation has a peculiarity: the right answer is not a matter of taste, because for most documents there is a source that settles it. Sometimes that is an already approved wording, sometimes an established template, sometimes the terminology you introduced in your own protocol.
So when you place the order we ask three things: which document type this is, which market it is for, and whether an earlier approved version exists. That third answer saves the most, because we continue from it rather than inventing the terminology afresh.
| Document | Most sensitive part | Source we follow |
|---|---|---|
| SmPC and package leaflet | dosage, contraindications, adverse reactions | the approved wording and the established templates for that market |
| Informed consent form | comprehensibility to a layperson, not technical precision | language pitched at an ordinary reader, abbreviations spelled out |
| Clinical trial protocol | inclusion and exclusion criteria, endpoints | the protocol’s own terminology, held across the whole file |
| GMP certificate, batch record | batch, equipment and manufacturing-site identifiers | codes are neither translated nor tidied |
| Regulatory dossier | names of active and excipient substances | the international non-proprietary name for actives, the Ph. Eur. name for excipients, never the brand |
Text the patient reads
The package leaflet and the informed consent form carry the opposite brief to the rest of the documentation: they must be understood by someone with no training in the field. A technically impeccable translation the patient cannot follow is a failure here, not a mark of quality.
So we work in shorter sentences, spell out abbreviations at first use, and avoid constructions that read awkwardly only because they mirror the structure of the original. Where the source wording is already unclear, we flag it rather than carry the ambiguity forward.
Clinical trials: consistency across the file
In a clinical trial you are not translating one document but a file that accumulates over years: the protocol, its amendments, the investigator’s brochure, forms and reports. Let the terminology drift between them and the contradictions surface at inspection, with you doing the explaining.
So from the first document we open a study glossary and a translation memory, and every later document builds on them. An amendment then continues the original wording instead of introducing a new word for the same concept.
Confidentiality and who sees the text
Regulatory and clinical documentation is a trade secret even where it contains no personal data. We work under an NDA, only the translator and the reviewer see the document, it never goes through public machine translation engines, and on request we delete the working files after delivery.
Where you have your own procedure for handling documentation, or require a particular delivery method, we agree it before the work starts rather than after.
How we work
- 1Tell us the document type and marketSmPC, informed consent, protocol or GMP record, and for which market. If an earlier approved version exists, send it.
- 2We quote and fix the terminology sourcePrice, deadline and what we will follow: the approved wording, a template, or your glossary.
- 3Translation and specialist reviewA translator with a pharmaceutical background does the work, and a second pair of eyes checks dosages, units and identifiers.
- 4Delivery, with the memory keptYou receive the document in its original format. The study glossary and memory stay on file for the next documents of the same submission.
Prices
- Regulatory and clinical documentation dossiers, protocols, reports, correspondence with the regulatorindividual quote
- SmPC and package leaflet following the established templates and the approved wordingindividual quote
- Follow-on document from the same file from the study glossary and memory you pay only for genuinely new partsindividual quote
Pharmaceutical translation is priced by volume, document type and whether it continues an earlier approved wording: a follow-on document costs less than the first. Send the material and we will prepare an exact quote.
FAQ
Do you translate medicine names?
Active substances are given by their international non-proprietary name (INN): within the EU it is the same on every market. Where the local name differs (paracetamol and acetaminophen in the US, for instance) we give both. The brand name is kept as it stands, with the active substance added where the product is sold under a different name on that market.
Do you have experience with clinical trial documents?
Yes, including protocols, amendments, the investigator’s brochure and informed consent forms. We keep one glossary for the whole file, so documents produced years apart stay terminologically consistent.
How do you ensure an informed consent form is understandable?
We write it for a layperson: short sentences, abbreviations spelled out at first use, and no constructions that merely mirror the source. Where the original wording is itself unclear we tell you, rather than passing the ambiguity on.
Does pharmaceutical translation have to be sworn?
For regulatory and clinical documents usually not, since what matters there is technical accuracy. A sworn translation becomes necessary for documents an authority or court takes in, such as certificates and powers of attorney. Tell us where the document is going.
How long do you keep the document?
Working files are deleted after delivery on request. For a sworn translation, though, one copy stays with the translator: § 23(7) of Act No. 382/2004 Z. z. requires them to keep it for ten years from the date it was made. Everything else can be deleted; that statutory copy cannot.
Updated: 2026-09-11
