PHARMACEUTICALS From First-In-Human to Launching the Brand – We Speak your Language.The latest research from Deloitte found that the average cost to develop a pharmaceutical product from discovery to launch is now $2.23 billion. With such large upfront investment, unnecessary delays in global clinical trials or regulatory submissions cannot be tolerated. And global clinical development is truly a global endeavour. From pivotal RCTs recruiting patients across multiple countries, to regulatory submissions requiring multilingual labelling that goes beyond translating words – accurate, high-quality translation is not optional. Language Insight is a trusted language partner across the full pharmaceutical lifecycle, with experience in dozens of therapeutic areas and all content types Get a quote Our pharmaceutical translation services Clinical trial materials We translate the full suite of clinical trial documentation: study protocols, amendments, investigator brochures (IBs), case report forms (CRFs), informed consent forms (ICFs), and patient-facing materials. Our clinical trial translators understand are well versed in GCP requirements and are experienced in the expectations of ethics committees across multiple jurisdictions. Regulatory submissions & dossiers From Module 1 regional administrative documents to Module 5 clinical study reports, we translate regulatory submissions in eCTD and paper format for national competent authorities worldwide. Our project teams include regulatory translation specialists who understand both the science and the submission requirements. Labelling & packaging Product labelling, including outer cartons, immediate labels, blisters, and vials – all must meet the precise requirements of each market's regulatory authority. We manage multilingual labelling projects with rigorous version control, barcode and artwork coordination, and a final label accuracy check before sign-off. Summary of Product Characteristics (SmPC) & Package Leaflets (PIL) for European MAA SmPCs and PILs must be maintained in all approved languages throughout a product's lifecycle. We translate, update, and manage these documents across your portfolio, including consistency with standards such as QRD for the EMA – with processes and tools ensuring consistency, so that changes in one language are applied harmoniously across all others. Medical Writing Support & Scientific Publications For organisations publishing in international journals or preparing medico-legal documents for cross-border use, we provide translation support for manuscripts, clinical study reports, and scientific communications – with linguists who understand the conventions of scientific publication. We are also able to resource medical writing for clinical and regulatory documentation. GxP-ready processes Our pharmaceutical translation workflows are designed to support GxP compliance – with full audit trails, controlled document handling, and staff training records available on request. Keeping your data safe We know and understand the importance of security and confidentiality when providing life sciences translation services. We are committed to protecting your data, which has been proven by our ISO 27001 information security management certification.We are the sole users of our dedicated fibre leased broadband line for transferring all data and we ensure that all our files are returned to you via our secure client portal. We also have in‑office security procedures to guarantee all client data is safe and secure. To find out more about how our security systems benefit our clients, visit our security and confidentiality page. Explore our range of Medical Language Services: Diagnostics Read More Life Sciences Read More Medical Devices Read More Get a quote If you’re interested in any of our language services and would like a free quote, please fill out our ‘get a quote’ form and a member of our Business Development team will contact you. Get a quote Here’s why you need us Sectors Our experience in transcription, translation, interpreting and other language services spans a range of sectors and specialisations. View sectors Our Teams Our teams are our greatest asset. We select all of our in‑house and in‑country experts for their experience and commitment to quality. Our Teams Quality Assurance Quality is at the core of everything we do. Without it, we can’t pride ourselves on being your trusted language partner. View quality assurance
