Life Sciences · Clinical Research · Regulatory Affairs

Life Sciences Translation:
What Pharma, CRO and Regulatory Teams Need to Know

A practical guide to translation and linguistic services for clinical trials, pharmacovigilance, regulatory submissions, and medical devices — from an ITI Corporate Member agency.

By TranslationsInLondon Ltd  ·  Updated May 2026  ·  10 min read

In life sciences, the margin for error in translation is effectively zero. A mistranslated adverse event narrative can delay a safety signal. An ambiguous informed consent form can invalidate a trial site. A poorly localised patient-reported outcome instrument can corrupt the data that underpins a regulatory submission.

At TranslationsInLondon, we work with pharmaceutical companies, contract research organisations, and regulatory affairs teams across the UK and Europe. This guide sets out what life sciences translation actually involves — the document types, the regulatory requirements, and the quality standards that separate compliant translation from mere text conversion.

In this guide

Section 01

Pharmacovigilance Translation

Pharmacovigilance (PV) translation is one of the most time-sensitive and high-stakes areas of life sciences language work. Adverse event reports, individual case safety reports (ICSRs), and periodic safety update reports (PSURs) must be translated accurately, promptly, and in compliance with EMA Good Pharmacovigilance Practice (GVP) guidelines.

The clinical narrative — the core of any ICSR — demands not just medical accuracy but the ability to render a coherent, readable account from source material that is often fragmentary, inconsistent, or written in a non-native language. A translator working in this space must understand MedDRA terminology, signal detection principles, and the causality assessment frameworks used by pharmacovigilance departments.

Our PV linguists work in Dutch, German, French, Italian, Spanish, Polish and other European languages — with English as the target language for all regulatory submissions to the EMA and MHRA. Learn more about our pharmacovigilance translation services →

Section 02

Clinical Trial Translation

Clinical trials generate an enormous volume of multilingual documentation — from site-facing materials that must be technically precise, to patient-facing documents that must be clear, accessible, and culturally appropriate. Both demands must be met simultaneously, and both carry regulatory weight.

Informed consent forms (ICFs) in particular sit at the intersection of legal, ethical, and clinical requirements. Under EU Clinical Trials Regulation 536/2014, ICFs must be written in language that trial participants can genuinely understand — not just translated from a technical source document. Patient information sheets, protocol summaries, and diary cards all require the same balance of precision and accessibility.

Section 03

Regulatory Submission Translation

Regulatory submissions to the EMA, MHRA, or national competent authorities require translation of complex, technically dense documents where every term must be consistent with the approved terminology for that product, that molecule, and that therapeutic area.

Common Technical Document (CTD) modules, Summaries of Product Characteristics (SmPCs), and package leaflets (PILs) must be translated using controlled terminology, with full version control and audit trail — and for patient-facing documents, with readability appropriate to the general population.

Section 04

Linguistic Validation & Independent Translation Review

Two related but distinct processes are frequently required alongside translation in clinical research contexts. Understanding the difference matters — not just for compliance, but for ensuring you commission the right service for the right document.

Both services produce formal written documentation and signed certificates submission-ready for EMA, MHRA, and ICH-compliant packages. Read our full guide to linguistic validation →

Section 05

Medical Device Translation

Under EU MDR 2017/745 and IVDR 2017/746, medical device manufacturers placing products on the EU market must provide documentation — labels, instructions for use (IFUs), technical files — in the official language of each member state. The requirements are explicit and non-negotiable, and the penalties for non-compliance are severe.

Device translation is not simply a matter of technical accuracy. Instructions for use must be understood by the end user — whether that is a trained clinician or a patient self-administering at home. The register, reading level, and cultural framing of the content must all be appropriate to that audience in each target market.

Section 06

Quality Standards in Life Sciences Translation

The life sciences sector demands demonstrable quality processes — not just assurances. When a CRO or sponsor asks about your quality framework, "we use experienced translators" is not an answer. The relevant standards are specific, and compliance with them requires documented processes, qualified personnel, and verifiable audit trails.

Get in touch

Discuss your life sciences translation project

Whether you need pharmacovigilance translation, clinical trial materials, regulatory submissions, or linguistic validation — we are happy to discuss your requirements, timelines, and language combinations.