Instructions for use, labelling, clinical trial documents, regulatory submissions, pharmacovigilance and patient information, delivered around your submission and study timetable.
When a study is running or a submission window is approaching, the linguistic work has to follow the same timetable as the rest of the file: the protocol lock, the labelling artwork, the filing date. Talkbridge works with pharmaceutical companies, contract research organisations and medical device makers who need accurate medical and life-sciences translation without a long induction into how that documentation is produced.
This page is about that operational work: the documents, the terminology and the deadlines. For the wider technical service line, including engineering manuals that often sit alongside device files, see our technical translation service.
A typical brief arrives as an IFU set, a labelling pack, a protocol and report bundle, or a folder of quality and regulatory files, often with a date that will not move. Sometimes the English master is still being reviewed while a submission or study start is already in the diary. We can start from a near-final draft and take a controlled update when the text is locked, so the rest of the team is not left waiting for a single large delivery.
We translate the materials that sit around a product or a study:
Clinical trial documentation has to stay consistent from the protocol through the report and any related narratives your team supplies. Preferred terms, product names and study-specific wording should not drift from one file to the next. We keep terminology in a translation memory and a project glossary so later drafts reuse approved wording. When a passage does change, we can show you what was edited so the reviewing medical or regulatory writer is not left guessing.
As described on our technical translation service, we apply GxP and ICH guidelines and keep terminological accuracy strict in healthcare contexts. That is a working discipline on the files you send us. It is not a certification of your submission, and it is not a guarantee of regulatory acceptance.
Instructions for use, labels and packaging have to stay unambiguous after translation, because clinicians and patients will act on that wording. The same product names and preferred terms should appear on the IFU, the label and any patient information leaflet or SmPC that belongs to the same product family. We build or extend a project glossary so those terms, and any banned variants you give us, are applied file after file.
If a project also includes engineering manuals or other technical files, we can coordinate terminology with the same technical service line, including the Medical & Life Sciences Translation English to German page when the work is between English and German.
Pharmacovigilance and safety communications, together with quality system files destined for submissions or audits, often arrive as a steady flow rather than a single pack. Deadlines are set by the safety case or the audit date, and the translations have to be ready before those dates, not after. Typical throughput is around 2,000 words per translator per working day. When a filing date is fixed, we can assign more linguists in parallel and still keep a second-linguist revision under ISO 17100 in the critical path.
Professional training and scientific content for specialist audiences follows the same terminology rules as the regulated files around the product. Tell us the language list, the volume and the deadline as early as you can; that is usually enough to plan capacity.
Life-sciences material is confidential by default. Every translator, reviewer and project manager signs an NDA before receiving access to the material. Access is limited to the people assigned to the project. If your procedures require a project-specific NDA, say so at briefing and we will sign it before the files are shared. You can also email [email protected] to arrange that first.
Assignments go to linguists from a network of over 5,000 professionals, with at least five years of professional experience, matched to medical or scientific subject matter. Delivery follows ISO 17100 translation and revision, not a single unchecked pass.
To price a project we need the source files or a word count, the language list, the deadline and the document class. Talkbridge LTD was founded in 2010 and is registered in Tortola, British Virgin Islands (company no. 1664226). We do not charge VAT. For a language-specific outline, see Medical & Life Sciences Translation English to German, or email [email protected].
IFUs, labelling and packaging, SmPCs and patient information leaflets, clinical study protocols, reports and related narratives, pharmacovigilance and safety communications, quality system and regulatory documentation for submissions or audits, and professional training or scientific content for specialist audiences.
We use translation memory and a project glossary so approved wording, including product names and preferred terms, is reused unless you ask us to revise it.
About 2,000 words per translator per working day. We can move faster with more linguists when the date is fixed, still with revision under ISO 17100.
Every translator, reviewer and project manager signs an NDA before receiving the files. Access is limited to the people assigned to the project. A project-specific NDA can be signed before we start.
It sits under our technical and life-sciences service line. This page is for operational work with pharma companies, CROs and medical device makers. The technical translation service page covers the wider document types, including engineering files that may sit alongside a device brief.
ISO 17100 processes, a network of over 5,000 translators, a minimum of five years' professional experience, founded in 2010, Tortola, BVI, no VAT. Contact: [email protected].
Request a quotation for your next medical or life-sciences project. Email [email protected].