Biotech Translation

What biotech teams send us

Preclinical study reports from contract labs abroad, certificates of analysis for materials, correspondence with foreign regulators, investigator brochures and protocols for foreign sites, consent forms and patient materials, licensing agreements with foreign partners, and patent documents. Early-stage companies often need a handful of documents fast; later-stage companies need whole modules of a submission translated consistently.

Into English for FDA

A translated study report becomes part of the application. It must be complete, keep the structure of the original (sections, tables, figure legends, appendices), and reproduce numbers, units and statistical results exactly. Methods sections are translated with the standard English names for assays, reagents and equipment; catalogue numbers and lot numbers are untouched. Where the original uses a term in a non-standard way, we keep it and add a translator's note rather than correcting the science.

Out of English for trials

Consent forms, patient diaries, recruitment material and instructions for participants are translated into each site's languages, at a reading level close to the English. Ethics committees and IRBs usually ask for a certificate of accuracy, sometimes a back-translation. Plan the language list early: a trial in Belgium may need Dutch, French and German versions of every participant document.

Terminology that must not drift

Gene and protein names follow official nomenclature (HGNC symbols for human genes, for example), species names stay in Latin, and the product's code name or INN is used consistently. We build a term list for each programme and keep it for later documents, so a construct or cell line has one name across reports, protocols and patents.

Licensing and partnerships

Licence, collaboration and material transfer agreements with foreign partners are contracts first. Field-of-use definitions, milestone triggers and IP clauses are translated exactly. If the agreement is bilingual, it should say which version governs.

Contract labs and CROs abroad

Much early biotech work is done by contract research organisations and labs in China, Korea, India and Europe. Their reports often come in English already, but raw data, lab notebooks, deviation reports and correspondence may not. When an auditor or reviewer needs to see the source, translate the specific records requested, page for page, with the lab's own numbering. A translator's note marks any handwritten entry that could not be read with certainty.