Instructions for use, user manuals, quick reference guides, technical specifications, product labelling, cybersecurity documentation and post-market surveillance materials - returned in the file formats your production workflow requires.
For Roche, one of the world's largest pharmaceutical and diagnostics companies, we translate diagnostics and pharmaceutical documentation, medical device materials and certified documents in Croatian, English, French, German and Hungarian.
Pharmacopoeia texts, SmPCs, package leaflets, patient information, drug labels and pharmaceutical quality documentation.
IFU documents, user manuals, technical specifications, product labelling and post-market surveillance materials.
Veterinary product authorizations, biologics documentation and regulatory communication for animal health products.
Technical files, product communication and recurring documentation for pharmaceutical packaging and supply chain materials.
Clinical trial documentation, informed consent forms, case report forms, ethics committee materials and research papers.
Patient information leaflets, consumer health product documentation and health monitoring device instructions.
Simultaneous and consecutive interpreting for pharmaceutical conferences, haematology events and medical congresses.
For regulatory submissions and official healthcare documentation requiring certified translation for submission to health authorities.
Veterinary product authorizations, biologics documentation, product information texts and regulatory communication - handled with the same regulatory awareness we bring to human healthcare content.
For CEVA-Phylaxia, a manufacturer of veterinary biological products and animal health solutions, we translate across 13 languages including Arabic, Chinese, Croatian, Danish, Dutch, English, Finnish, French, German, Hungarian, Norwegian, Romanian and Slovenian.
One of the world's largest pharmaceutical and diagnostics companies - diagnostics and pharmaceutical documentation, medical device materials and certified documents in Croatian, English, French, German and Hungarian.
Veterinary product authorizations, biologics documentation and regulatory communication across 13 languages including Arabic, Chinese and Norwegian.
Pharmacopoeia texts & Chinese-English pharmaceutical terminology.
Packaging documentation from English into Italian & other languages.
Japanese-English pharmaceutical terminology, scientific documentation.
Patient & product information across English, German, Hungarian.
Simultaneous interpreting for haematology conferences, EN & Russian.
Product documentation & website content, English & Hungarian.
Also: Cencora (formerly AmerisourceBergen) and its Skills in Healthcare division - healthcare and pharmaceutical service documentation and consumer health website content from English into Hungarian.
Patient information leaflets, consumer health product documentation, health monitoring device instructions and healthcare service materials - written to be accurate, clear and appropriate for the target audience in each language.
Pre-submission regulatory documentation and clinical trial materials are commercially sensitive. We operate under strict confidentiality procedures and are happy to sign NDAs before any documents are shared.
Our healthcare and life sciences translation work covers all EU member state languages and a range of non-European combinations where pharmaceutical distribution, device export and regulatory submissions require them.
Documented pairs include English, German, French, Italian, Spanish, Portuguese, Dutch, Polish, Czech, Slovak, Romanian, Hungarian, Bulgarian, Croatian, Serbian, Slovenian, Danish, Norwegian, Finnish, Swedish and Russian. A product entering 15 EU markets plus Arabic, Persian and Farsi-speaking markets needs a partner with genuine coverage across that full range.
IFU documents, SmPCs and product authorizations are regulatory instruments requiring translators with direct knowledge of the relevant frameworks.
A term approved in one regulatory submission must carry forward to all subsequent submissions and related documentation, in every language.
Genuine coverage across Arabic, Chinese, Japanese, Persian and Norwegian alongside the full EU set - not a Western European specialist who subcontracts the rest.
Regulatory submission windows are fixed. We are structured to handle urgent requests, with translators available for priority assignment.
Pre-submission regulatory documentation and clinical trial materials are commercially sensitive. We operate under strict confidentiality procedures and are happy to sign NDAs.
Our translators are familiar with EMA guidelines, EU MDR and IVDR requirements, and the terminology conventions expected in regulatory submissions. We do not offer regulatory consulting - a separate professional discipline - but our translators reduce the risk of terminology errors that create problems downstream.
Delivered under ISO 17100:2015 (translation services) and ISO 9001:2015 (quality management systems), audited by Certa-Nova - applying to translator qualification, mandatory independent revision, terminology management and delivery.
Yes. Instructions for use, user manuals, product labelling and technical specifications are among the most common document types we handle.
Yes. We have translated pharmacopoeia materials and scientific texts, including technically demanding Chinese-English pharmaceutical terminology.
Yes. Arabic, Chinese, Japanese and Persian are documented language directions in our healthcare and life sciences work.
Yes. We provide simultaneous and consecutive interpreting for pharmaceutical conferences, haematology events and specialist medical meetings.
Yes. NDA arrangements are standard for clients sharing regulatory submissions, clinical documentation or commercially sensitive content.
Yes. Certified translations with the appropriate certification statement, stamp and signature are available for regulatory purposes.
Whether it's a single patient leaflet or a multilingual IFU program spanning 22 languages, we will prepare a detailed proposal.