Specialist pharmaceutical translation for MHRA submissions, clinical trial documents, drug labelling, and regulatory correspondence — from £19.99 per page.
Pharmaceutical translation is its own world — narrower than medical translation, denser in regulatory language, and entirely B2B. We work with CROs, sponsors, and small biotech firms on MHRA submissions, clinical trial documentation (ICFs, IBs, study protocols), CIOMS adverse-event reports, drug labelling, and patient information leaflets. Every document needs to land at the same regulatory standard the originals were written to, in either direction.
The rate is £19.99 per page. Pharmaceutical work needs translators with regulatory training (often a pharmacy or life-sciences degree alongside translation qualifications), an established back-translation workflow, and a QC pass that flags any deviation from MHRA / EMA / FDA terminology conventions.
We translate MHRA regulatory submissions, clinical trial documents (informed consent forms, investigator brochures, study protocols, case report forms), CIOMS adverse-event reports, drug labelling, patient information leaflets (PILs), and pharmacovigilance correspondence. Each translation is certified with statement of accuracy and translator credentials.
Clinical trial documentation is the highest-volume stream — multi-country trials regularly need ICFs, IBs, and study protocols translated for each participating site, often with very short turnarounds when an amendment goes through. We work to ICH-GCP terminology standards and run a back-translation QC for ICFs at sponsor request.
Regulatory submissions for the MHRA cover Module 1.3 product information (SmPC, Patient Information Leaflet, labelling), Risk Management Plans, and post-authorisation safety variations. For drug labelling specifically, the QRD template (Quality Review of Documents) sets the language conventions we work within.
Clinical trial documents run on sponsor and CRO timelines, not standard SLAs. We assign dedicated pharmaceutical translators to each project and offer parallel processing across multiple language pairs for multi-site trials, with same-day turnaround for urgent protocol amendments.
A multi-country trial sending out a protocol amendment can need 8–12 language pairs translated and back-translated inside a week. We handle this by assigning a per-project lead translator who maintains terminology consistency across the language pairs, with parallel translators handling each pair under the lead's QA.
For ICFs specifically, sponsors increasingly require back-translation as a quality control step — the document is translated to the target language, then a separate translator translates it back to English without seeing the original, and the two English versions are compared for divergence. We bundle this into pharmaceutical orders on request.
Pharmaceutical translation costs from £19.99 per page. This covers a translator with regulatory background (typically pharmacy or life-sciences qualifications), QC against MHRA / EMA / FDA terminology, and an ICH-GCP-aligned process. Back-translation and terminology management are quoted on a per-project basis.
Per-page pricing applies to standard documentation. Long-form clinical trial work (multi-country protocols across 8+ language pairs) is usually quoted on a per-project basis to cover the lead-translator coordination and terminology management overhead. We work directly with CRO procurement teams on framework agreements for ongoing trial portfolios.
Yes — CROs and sponsors are our core pharmaceutical client base. We hold framework agreements with several CROs running multi-country trials and can be onboarded as an approved vendor on your standard procurement terms.
Yes. SmPC, Patient Information Leaflet, and labelling under the QRD template are part of our regulatory translation workflow. We track current QRD versioning and align to the conventions MHRA expects on UK submissions.
Yes. Back-translation is offered as an add-on for informed consent forms and other patient-facing trial documents where sponsors require it. The forward and back translations are handled by separate translators who don't see each other's work, and the comparison is reviewed by a third linguist.
Our pharmaceutical translators have life-sciences or pharmacy qualifications (B.Pharm, Pharm.D, life-sciences degrees) combined with translation qualifications, with sustained CRO or pharma sector experience. Specialist therapeutic areas (oncology, rare diseases, vaccines) are routed to translators with matching subject-matter depth.
Standard amendments are 24–48 hours per language pair. Urgent amendments (safety updates, sponsor-requested protocol changes with site activation deadlines) can be handled same-day with parallel translation across language pairs. Get in touch via WhatsApp or email for time-critical work.
Yes. We sign sponsor / CRO confidentiality agreements, quality agreements (where regulatory inspections may apply), and data processing agreements as standard. Vendor onboarding is usually a 1–2 week process depending on the depth of audit required.
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