Life Sciences Translation Services

Life sciences translation occupies a unique position at the intersection of linguistic precision and scientific accuracy. The field encompasses molecular biology, genetics, pharmacology, and clinical research, each with extensive specialised vocabularies and evolving terminology as new discoveries reshape understanding. Translators must not only master these vocabularies but understand the science sufficiently to recognise when something doesn't make sense.

The stakes in life sciences translation are high. Clinical trial protocols must be translated with absolute precision to ensure patient safety and data integrity across international study sites. Regulatory submissions to the FDA, EMA, or MHRA must use exact terminology that regulators expect. Scientific publications must maintain the nuance and precision that peer reviewers demand. Patent applications must use language that protects intellectual property whilst satisfying patent office requirements.

Our life sciences translators hold advanced degrees in relevant fields, PhDs in biochemistry, molecular biology, pharmacology, or related disciplines. Many have research experience in academic or industry settings. They understand experimental methodology, statistical approaches, and the context in which scientific findings are reported. This scientific foundation enables them to translate not just words but meaning.

Regulatory translation in life sciences requires understanding of both the science and the regulatory frameworks governing drug and device development. Each regulatory authority has specific requirements for translated documentation, and submissions must satisfy these requirements to avoid delays in the approval process.

Our regulatory translation approach includes:

• FDA submissions, IND (Investigational New Drug) applications, NDA (New Drug Application) filings, and BLA (Biologics License Application) submissions have specific requirements. We translate according to FDA guidance documents and established terminology conventions
• EMA submissions, Marketing Authorisation Applications to EMA require documentation in English with specific components potentially requiring translation into other EU languages. We understand the Centralised Procedure, DCP, and MRP requirements
• MHRA submissions, Clinical Trial Authorisations and Marketing Authorisations to MHRA follow UK-specific requirements post-Brexit. We ensure submissions meet current MHRA guidance
• Back-translation and reconciliation, For critical regulatory documents, we provide back-translation from target language to source, followed by reconciliation to verify accuracy. This provides auditable documentation of translation quality
• Audit trail documentation, Regulatory submissions may require translator CVs, signed statements, and quality certifications. We provide complete documentation packages suitable for regulatory inspection

When a questionnaire measures a study endpoint, translation becomes a measurement problem: the translated instrument must measure the same thing as the original or the data cannot be pooled across countries. Linguistic validation answers that with a defined sequence of dual forward translation, reconciliation, independent back translation, clinician review and cognitive debriefing with target-language respondents, documented in a full audit trail suitable for submission.

We run linguistic validation to recognised good practice as part of our clinical trial translation service, and we scope it honestly: endpoint instruments warrant validation, administrative study documents need excellent standard translation, and we will tell you which of your documents fall on which side of that line before you spend a penny at validation rates.