Regulated specialised translation with liability
Specialised translation services for Pharmaceuticals & Chemicals
GMP documentation, regulatory submission dossiers and safety data sheets, translated accurately, audit-ready and with strict confidentiality.
ISO 17100 · ISO 18587 · ISO 9001 · four-eyes principle · NDA practice
In pharmaceuticals and chemicals, specialised translation is not a marketing instrument but an integral part of regulatory compliance. Package inserts, safety data sheets and regulatory submission dossiers are legally regulated documents: Your linguistic accuracy governs your market access, patient safety and liability. Just one incorrectly rendered unit, a misplaced dosage specification or an imprecise warning notice can result in regulatory objections, delivery stoppages or product recalls.
The pharmaceutical world is defined by marketing authorisation: Product information follows the requirements of the EMA and the national authorities. Manufacturing and testing are documented in accordance with GMP. After marketing authorisation, pharmacovigilance creates an ongoing, deadline-driven need for translations.
Our knowledge page explains in detail what GMP requires for translations, from SOPs through to package leaflets. GMP-Compliant Translation.
In the chemicals industry, safe handling of substances is paramount. REACH and the CLP Regulation govern registration, classification and labelling, from the safety data sheet with its 16 sections through to the label with officially defined H and P phrases. Employees who work with hazardous substances every day need to be able to rely on every single translated line.
Request a project & get advice
Do you have technical documents that need translating? Send us 1–2 sample files. You will receive a specific recommendation and a quote within 24 hours.
Three value promises
Correctness under liability
Every specialised translation is carried out according to the four-eyes principle in line with ISO 17100: A second qualified specialised translator reviews the content, completeness and language. Critical content (dosages, units, H and P statements) is specifically checked and the quality assurance is documented.
Confidentiality
Registration dossiers and research data are among the most valuable assets a company possesses. All employees sign non-disclosure agreements. Data is processed in a GDPR-compliant manner on EU servers, and translation memory and terminology resources are strictly segregated for each client.
Terminology governance
A central terminology glossary and the translation memory ensure consistency across product generations, dossier updates and variants. When changes are made, only the new content is translated. The reviewed remains exactly as it is.
Two worlds
Pharmaceuticals and chemicals follow different regulatory frameworks, yet they share the GMP environment, mandatory documentation requirements and a commitment to absolute precision. That is why we treat both separately and then align them within the process.
World 1
Pharmaceuticals / Life Sciences
- Marketing authorisation & product information: eCTD dossiers, SmPC, package leaflet and label according to the EMA QRD templates.
- GMP documentation: SOPs, manufacturing and testing instructions, qualification and validation in accordance with EU GMP Annex 15 (IQ/OQ/PQ).
- Clinical trials: Study protocols, informed consent forms and study reports in accordance with GCP.
- Medicinal product safety: Pharmacovigilance reports (PSUR), stability studies and correspondence with regulatory authorities.
World 2
Chemicals / Process Industry
- Regulation of chemicals: Registration and evaluation documentation under REACH, classification and labelling under CLP/GHS.
- Safety Data Sheets: multilingual SDSs in accordance with REACH Annex II, with identical structure and consistent terminologically and labelling.
- Labels & warnings: official H and P statements, signal words and pictogram texts in the applicable language version.
- Process and plant documentation: Process descriptions, operating instructions and explosion protection documentation (ATEX), forming the bridge to plant engineering and packaging machinery.
Standards and regulatory frameworks at a glance
| Regulatory framework | Relevance for translation | Area |
|---|---|---|
| Good Manufacturing Practice (GMP) | Manufacturing and test documentation, SOPs and training materials, auditable in any language | Pharma / Chemicals |
| EU GMP Annex 15 | Qualification and validation: IQ/OQ/PQ protocols and reports. | Pharma |
| European Medicines Agency (EMA) | Centralised marketing authorisation; QRD templates for product information in all EU official languages | Pharma |
| ICH guidelines | including ICH Q7 (GMP for active substances), ICH E6 (Good Clinical Practice), Q1 series (stability). | Pharma |
| 21 CFR Part 11 (FDA) | Electronic records and signatures for the US market; CSV documentation requirements. | Pharma / Chemicals |
| REACH Regulation (EC) No. 1907/2006 | Registration and evaluation of chemicals; obligation to provide a safety data sheet | Chemicals |
| CLP Regulation (EC) No. 1272/2008 (as amended by Regulation (EU) 2024/2865) | Classification, labelling and packaging, including H statements, P statements and signal words. | Chemicals |
The regulatory frameworks in both worlds are shifting: The EU pharmaceutical package (the largest reform of European medicines legislation in over twenty years) was published in its final form in March 2026 following the political agreement reached in December 2025. Formal adoption by the Council and Parliament is expected in 2026. It replaces Directive 2001/83/EC and Regulation (EC) No 726/2004, subject to transitional periods. This is expected to create a need for adjustments to product information in all language versions. In the chemicals sector, the CLP revision, Regulation (EU) 2024/2865, introduces new requirements for label format, re-labelling and distance selling. The application date for key new obligations has been postponed to 1 January 2028 by the "stop-the-clock" Regulation (EU) 2025/2439. Anyone who manages labels and safety data sheets in multiple languages should plan re-labelling at an early stage. Consistently maintained terminology and an up-to-date translation memory turn these changes into routine instead of a major project.
Status as of July 2026; information without guarantee. The decisive factors are the applicable EU legal acts and the national requirements in the target markets.
Documents we translate for you:
Languages for marketing authorisation and product labelling
For EU marketing authorisation and hazardous substance labelling, we deliver complete language sets from a single source, consistently managed in a translation memory.
Quality you can rely on
ISO-certified processes
Translation in accordance with ISO 17100, post-editing in accordance with ISO 18587, quality management in accordance with ISO 9001.
Specialised translators with industry expertise
Native linguists with experience in pharmaceuticals, chemicals and life sciences.
Structured QA and terminology control
Four-eyes principle, documented checks, central glossary, version and change management.
Confidentiality
Established NDA practice, GDPR-compliant processing, EU server, segregated data sets for each client.
Related expertise from COMLOGOS
Medical Technology
IFU, labelling and regulatory documents in accordance with MDR/IVDR, translated in an audit-ready way for global markets. With combination products, both worlds come together.
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Packaging Machinery
GMP-compliant packaging technology, EHEDG, CIP/SIP, documentation for the pharmaceutical and food industries.
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Plant Engineering
P&ID, process descriptions, explosion protection (ATEX), consistent throughout the entire plant lifecycle.
Learn moreThe right services & technologies
Frequently asked questions about specialised translation in pharmaceuticals and chemicals
Why are translations in pharmaceuticals and chemicals relevant for liability?
Because the translated documents themselves form part of regulatory compliance. An incorrect package leaflet puts patients at risk, and an inaccurate safety data sheet puts employees at risk. Both can trigger regulatory objections, product recalls and liability cases. This is why we work with the four-eyes principle in accordance with ISO 17100, documented quality assurance and focused review of critical content such as dosages, units and safety warnings.
What does GMP-compliant translation mean in practice?
Traceability: defined processes, qualified specialised translators, revision by a second person, version control and documented approvals. Every step can be demonstrated in an audit. Translation memory and terminology database ensure that an SOP in version 12 uses the same terminology and wording as in version 3.
How can safety data sheets (SDS) be translated correctly into multiple languages?
The 16-section structure in accordance with REACH Annex II remains unchanged; only the content is translated. H and P statements, signal words and classification information are not formulated freely but taken from the official language version of the CLP Regulation. The safety data sheet must be provided in the language of the Member State in which the substance is placed on the market and must match the label exactly in terms of terminology.
What language requirements apply to the EU marketing authorisation of medicinal products?
For centrally authorised medicinal products, the product information (summary of product characteristics, package leaflet and labelling) must be available in all official EU languages and must be structured in line with the EMA QRD templates. For national procedures, the official language of the respective Member State applies. We deliver QRD-compliant language versions from a single source and ensure that standard passages remain fully consistent with the approved templates.
How do you ensure consistent terminology across dossier updates?
At the start of the project, we create a central terminology glossary that is binding for all documents and languages. The Translation Memory then stores every approved translation. With updates, only the new content is translated. The verified content remains exactly as it is. This way, the dossier, package leaflet and SOP stay consistent over many years.
How do you handle confidential marketing authorisation data and research data?
All employees and translators sign non-disclosure agreements. Processing is GDPR-compliant and takes place on EU servers. Translation memory and terminology assets are kept strictly separate for each client. Our ISO 9001 processes make access rights and responsibilities clearly traceable.
Do you also provide translations for the US market (FDA, 21 CFR Part 11)?
Yes. We translate documentation for FDA submissions as well as SOPs and validation documents in relation to 21 CFR Part 11, for example on Computer System Validation (CSV). English-language versions are created with native-speaker specialist revision and consistent validation terminology (IQ/OQ/PQ).
How is this page different from your Medical Technology page?
The Medical Technology page covers devices, software and their documentation in accordance with MDR and IVDR: IFUs, labelling and regulatory documents. Here the focus is on active ingredients, substances and processes: Marketing authorisation, GMP, REACH and CLP. For combination products (drug–device combinations), both worlds work closely together. Simply get in touch with us.
Let’s talk about your project in pharmaceuticals or chemicals.
Send us 1–3 sample documents, for example a safety data sheet, an SOP excerpt or a marketing authorisation text. You will receive a well-founded assessment of the effort involved, the process and the terminology development. Confidential, binding, with no detours.
ISO 17100 · ISO 18587 · ISO 9001 · four-eyes principle · NDA practice
