ISO 17100:2015 Certified · Pune, India
Medical Translation Services in Pune
Regulated industries cannot afford translation errors. When a patient information leaflet, regulatory dossier, or clinical document needs to be accurate in another language, the translator needs domain expertise, not just fluency. Wordsmith Language Solutions has provided medical translation services since 2013, working with pharmaceutical companies and medical device manufacturers across India and abroad.
ISO 17100:2015 and ISO 9001:2015 Certified · 5,000+ Linguists · 300+ MNC Clients
What Medical Translation Covers
Medical translation is not a general service. It is a specialised discipline that sits at the intersection of linguistic precision and regulatory compliance. A single mistranslation in a patient consent form, a drug label, or an instructions-for-use document can have serious consequences for patients and significant liability exposure for manufacturers.
At Wordsmith Language Solutions, medical translation projects are handled exclusively by translators with documented subject-matter expertise in the relevant medical or pharmaceutical domain. Every translator on a regulated project signs a project-specific NDA. Every file goes through a review stage before delivery. This is how we have maintained a 98% satisfaction rate across 300+ MNC clients since 2013.
Our technical translation capabilities extend into the medical field across a wide range of document types, and our pharmaceutical translation service covers the full regulatory lifecycle from development to post-market surveillance.
Medical Documents We Translate
We handle the full range of documents that pharmaceutical companies, medical device manufacturers, and healthcare organisations need in multiple languages.
Instructions for Use and Device Manuals
Instructions for use (IFUs), technical files, CE marking documents, labelling, and operator manuals for medical devices. Translated in compliance with ISO 15223-1 and EU MDR requirements across all required languages.
Patient-Facing Documents
Informed consent forms, patient information leaflets, discharge summaries, patient records, and patient-reported outcome questionnaires. Plain-language accuracy is as important as regulatory precision for this document type.
Pharmaceutical and Regulatory Documents
Drug labels, package inserts, SmPCs, regulatory dossiers for CDSCO, USFDA, or EMA, and product monographs. Terminology consistency across a dossier is maintained through project-specific glossaries.
Research Papers and Clinical Summaries
Peer-reviewed journal articles, clinical study summaries, literature reviews, and biomedical research papers. Translated by linguists with relevant academic or clinical backgrounds in the subject area.
Medical and Pharma Patents
Patent applications, patent claims, freedom-to-operate reports, and prior art searches in the medical and pharmaceutical fields. Precision in claim language is critical. Our patent translators are also subject-matter experts in the relevant technical domain.
Medical Contracts and Agreements
Clinical trial agreements, licensing agreements, distribution contracts, and regulatory submission cover letters. These documents sit at the intersection of medical and legal translation, and we apply expertise from both disciplines.
How We Handle Medical Translation Projects
Regulated industries require a translation process that is documented, traceable, and verifiable. Here is how a medical translation project runs at Wordsmith Language Solutions.
Project Scoping and NDA Signing
We review the document set, confirm the language pairs, identify the relevant regulatory context (CDSCO, EU MDR, USFDA, or other), and match the project to translators with the right domain background. Every translator assigned to your project signs a project-specific NDA before receiving any file.
Glossary and Style Guide Creation
For multi-document or ongoing projects, we build a client-specific glossary to ensure consistent terminology across all translated materials. This is especially important for regulatory dossiers, where a term used differently across documents can raise questions during review.
Translation by a Domain Expert
The primary translator is selected from our network of 5,000+ verified linguists based on their documented expertise in the relevant medical or pharmaceutical sub-field. General medical translators are not assigned to regulatory documents. The right expert is assigned for every project.
Review by a Second Medical Linguist
A second subject-matter expert reviews the translation independently. This two-translator model is a requirement of ISO 17100:2015, which governs our translation process. The reviewer checks accuracy, terminology consistency, regulatory alignment, and target-language fluency.
Back Translation (Where Required)
For clinical trial documents, patient-reported outcome questionnaires, and other materials where regulatory bodies or sponsors require it, we offer a formal back translation process. A third, independent translator renders the target-language text back into the source language without seeing the original. A trained reviewer then maps every discrepancy between the original and the back translation to produce the most accurate final draft. This step is standard practice for USFDA and EMA submissions involving patient-facing content.
Delivery with Documentation
Final delivery includes the translated documents and, where required, a translator's statement of accuracy or a back translation reconciliation report. Turnaround is agreed before work begins and met without revision requests. Projects that need multilingual DTP formatting are handled in-house. Contact us to discuss your project timeline.
Languages We Cover for Medical Translation
Wordsmith Language Solutions covers 120+ languages for medical and pharmaceutical projects. Below are the language pairs most frequently requested by our healthcare and pharma clients.
| Language Pair | Common Use Cases |
|---|---|
| German to English | EU MDR submissions, medical device IFUs, clinical study reports, German pharmaceutical labelling |
| English to German | Regulatory dossiers for German-market product registration, CE marking documentation |
| French to English | EMA submissions, clinical trial documents from French-language CROs, patient information leaflets |
| Japanese to English | PMDA submissions, Japanese medical device manuals, clinical data reports from Japanese sponsors |
| Marathi, Hindi to English | Patient consent forms, hospital records, diagnostic reports for CDSCO or legal purposes |
| English to Marathi, Hindi | Patient-facing leaflets for Indian markets, clinical site documents for Indian investigators |
Not on this list? We cover 120+ languages. Contact us to confirm availability for your language pair.
Why Pharma and Medical Device Companies Choose Wordsmith
There are many translation agencies. There are fewer that understand what a regulatory submission actually requires. Here is what sets Wordsmith Language Solutions apart for medical clients.
ISO 17100:2015 Process, Not Just a Certificate
ISO 17100:2015 defines how a professional translation should be produced. It requires qualified translators, a mandatory review stage, and documented project management. We are ISO 17100:2015 and ISO 9001:2015 certified, and every medical translation project follows this process without exception.
Subject-Matter Expert Translators Only
A fluent German speaker cannot reliably translate a pharmacokinetics study report without domain knowledge. Our 5,000+ linguist network includes professionals with backgrounds in pharmacology, biomedical engineering, clinical research, and regulatory affairs. The right expert is assigned to every project.
Project-Specific NDAs for Every Linguist
Confidentiality is not an optional feature for medical translation. Every translator assigned to your project signs a project-specific NDA before receiving any file. Our data-handling record across 10+ years and 300+ MNC clients has been clean. We intend to keep it that way.
Formal Back Translation Service
For clinical trials, patient-reported outcome instruments, and regulatory submissions that require it, we provide a structured back translation process. An independent third translator renders the target text back into the source language. A reviewer then maps every discrepancy to produce the most accurate final draft. This is a recognised quality standard for USFDA, EMA, and ICH submissions.
Up to 50,000 Words Per Day Delivery Capacity
Regulatory timelines do not wait. With a delivery capacity of up to 50,000 words per day across multi-translator project teams, Wordsmith Language Solutions can match the pace of a regulatory submission cycle. Large dossiers are planned as projects with milestones, not treated as single files.
Medical Translation at Scale: A Case Study
Scale and accuracy are rarely easy to achieve at the same time. This project is an example of how Wordsmith Language Solutions manages both.
The Challenge
A globally recognised medical research institute in Pune required their clinical research papers, produced for ICMR-funded dissemination, to be made accessible in nine Indian vernacular languages. The papers covered respiratory disease research and contained precise clinical and statistical terminology that had to be rendered accurately in each target language. A standard translation was not sufficient. The project required a full back translation cycle to satisfy the quality standards expected for research dissemination at this scale.
What We Did
Each paper was first translated into the target language by a subject-matter expert with a documented background in medical or clinical research. A second, independent translator then back-translated the target text into English without access to the original. A senior reviewer at Wordsmith mapped every discrepancy between the original English and the back translation, identifying terminology choices that could introduce ambiguity or factual drift. The reconciled draft was then finalised and approved. This process was repeated across all nine language pairs and across the full 500,000+ word corpus.
The Result
The final translated corpus was accepted without revision requests. The back translation reconciliation process, run consistently across all nine languages, produced drafts of sufficient accuracy that no further correction cycles were required. For a project of this scale and linguistic complexity, that outcome reflects the discipline of the process as much as the skill of the translators.
For organisations with similar requirements, whether for clinical trial documents, patient-reported outcome instruments, or research dissemination, our medical translation team is available to discuss your project scope and timeline.
What Our Clients Say
Real feedback from businesses and individuals we have worked with since 2013.
"Finding an agency that accurately understands complex R&D patents and domain-specific jargon is tough, but Wordsmith delivers every single time. Their team is highly responsive, and the final translation quality requires zero internal rework from our engineers."
Vikram MalhotraLead R&D Engineer, Bhosari
"Very professional and reliable service. We recently handed over some dense, highly technical machinery manuals, and the translated copies were delivered flawlessly while maintaining the exact original layouts. Wordsmith makes the entire coordination process completely hassle-free."
Satish NairHead of Plant Operations, Pimpri
Frequently Asked Questions
How much does medical translation cost in Pune?
Medical translation pricing depends on the document type, language pair, and volume. Regulated documents such as IFUs and clinical trial materials require subject-matter expert translators, which is reflected in the rate. Contact Wordsmith Language Solutions for a project-specific quote.
How long does medical document translation take?
Turnaround depends on document length and complexity. Standard medical reports and patient records are typically completed within 24 to 48 hours. Large regulatory dossiers or multi-language projects are planned on a project timeline agreed before work begins. We deliver on time, every time.
Are your medical translators subject-matter experts?
Yes. Wordsmith Language Solutions assigns only translators with documented medical or pharmaceutical domain expertise to healthcare projects. Our 5,000+ linguist network includes professionals with backgrounds in pharmacology, clinical research, biomedical engineering, and medical device regulation.
Can you translate medical documents for regulatory submissions in India and abroad?
Yes. We translate documents for submissions to CDSCO, USFDA, EMA, and other regulatory bodies. Our ISO 17100:2015 and ISO 9001:2015 certified process ensures the accuracy and traceability that regulators expect. All linguists sign project-specific NDAs.
How do you ensure confidentiality of sensitive medical documents?
Every translator on a medical project signs a project-specific NDA before receiving any files. Documents are shared through encrypted channels. No medical document is retained beyond the agreed project period. Wordsmith Language Solutions has a clean data-handling record across 300+ MNC client projects since 2013.
Do you offer back translation for clinical and regulatory documents?
Yes. Wordsmith Language Solutions provides a formal back translation service for documents where it is required by a sponsor, CRO, or regulatory body. An independent translator renders the target-language text back into the source language without seeing the original. A trained reviewer then maps every discrepancy and resolves them to produce the most accurate final draft. This process is standard for USFDA, EMA, and ICH E6 compliant clinical submissions.
What languages do you cover for medical translation?
Wordsmith Language Solutions covers 120+ languages for medical translation, including German, Japanese, French, Marathi, Hindi, and other Indian languages. We handle both directions: Indian languages to English and European or Asian languages to English or vice versa.