ISO 17100:2015 Certified . Pune, India
A mistranslation in a regulatory dossier or a package insert can delay product approvals, trigger a recall, or create serious patient safety risks. Since 2013, Wordsmith Language Solutions has worked with pharmaceutical companies translating regulatory submissions, clinical trial documents, and product labelling with the precision and confidentiality this industry demands.
From regulatory submissions to patient-facing materials, we handle the full range of pharma documentation across the product lifecycle.
| Document Type | Typical Use Case |
|---|---|
| Regulatory Dossiers (CTD/eCTD) | Marketing authorisation applications for CDSCO, EMA, PMDA, and other global agencies |
| Clinical Trial Protocols | Multilingual trials requiring translated protocol documents for investigators across sites |
| Informed Consent Forms (ICF) | Patient-language informed consent for clinical trials and research studies |
| Investigator Brochures | Translated brochures for clinical site investigators in multinational trials |
| Package Inserts / Leaflets | Patient information leaflets and summary of product characteristics (SmPC) |
| Drug Master Files (DMF) | Technical submissions to regulatory agencies detailing drug substance or product data |
| Standard Operating Procedures (SOPs) | Manufacturing and quality SOPs for multilingual plant operations |
| Batch Records & Quality Documents | GMP batch manufacturing records, deviation reports, and quality audit documentation |
| Pharmacovigilance Documents | Individual Case Safety Reports (ICSRs), PSURs, and signal management documents |
| Material Safety Data Sheets (MSDS/SDS) | Regulatory SDS for chemical and pharmaceutical raw materials |
| Marketing Authorisation Applications | Complete MAA and NDA translations for new product submissions globally |
| Labelling and Artwork | Multilingual product labelling, carton artwork, and regulatory-compliant text |
We translate complete regulatory dossiers for submissions to CDSCO, EMA, PMDA, and other agencies. Our regulatory linguists understand ICH Common Technical Document format and the language requirements of each authority.
Multilingual clinical trials require consistent, compliant translation of study documents. We handle informed consent forms, investigator brochures, patient diaries, and CRF translations, with version control and glossary management across the trial lifecycle.
GMP environments demand absolute consistency in language across SOPs, batch records, and audit reports. We translate quality documentation with terminology locked to client-approved glossaries, ensuring the same term is used the same way every time.
Pharmaceutical documents are not business documents. They carry regulatory, legal, and patient safety implications. A word that is mistranslated in an informed consent form, or a term that deviates from the regulatory glossary in a dossier submission, can lead to a request for supplementary information, a submission rejection, or in patient-facing documents, a safety incident.
Pharmaceutical terminology is governed by controlled vocabularies: MedDRA for adverse events, INN nomenclature for drug names, ICH guidelines for clinical documentation, and agency-specific labelling requirements for CDSCO, EMA, and PMDA. A general linguist, no matter how fluent, does not inherently know these systems. A pharma-domain linguist does.
At Wordsmith Language Solutions, we assign only life sciences domain linguists to pharmaceutical projects. These are translators with academic or professional backgrounds in pharmacy, biochemistry, medicine, or related fields, who translate pharma documents regularly. They are familiar with GCP, GMP, and GLP terminology. They understand what a regulatory reviewer expects to read. And they use your approved terminology, not their own interpretation of it.
Our work on technical translation for regulated industries gives us a strong foundation. Pharmaceutical is one of the sectors where we apply the highest level of subject-matter discipline, alongside our work in medical translation services.
Consistency is a regulatory requirement in pharmaceutical translation. If a clinical trial uses the term "adverse event" in the protocol, that same term must appear in the CRF, the informed consent, the investigator brochure, and the final study report. Variations cause ambiguity. Ambiguity causes queries. Queries cause delays.
We build and maintain a client-specific glossary for every pharmaceutical project of meaningful scale. Terms are agreed with the client at the start, locked in, and applied by every linguist on the project. The glossary is updated as the project progresses and shared with the client for approval. When you work with us on the next submission, the same glossary applies.
Every pharmaceutical translation at WLS goes through a two-stage quality process: translation by a subject-matter linguist, followed by independent review by a second pharma-domain translator. This process aligns with the ISO 17100:2015 standard we are certified to. For documents with high regulatory sensitivity, we add a third stage: a senior review pass by a linguist with specific experience in the target regulatory environment.
We have experience preparing translations for submissions to the following regulatory authorities, meeting each agency's specific format and certification requirements.
Wordsmith Language Solutions is an ISO 17100:2015 and ISO 9001:2015 certified translation agency, founded in Pune, India in 2013. We are trusted by 300+ MNC clients across sectors, including leading pharmaceutical manufacturers in India and internationally. Our clients include Lupin, one of India's largest pharmaceutical companies.
A leading Indian pharmaceutical company engaged us to translate a regulatory submission package for a new drug application to the CDSCO. The project involved multiple document types, including the clinical summary, quality dossier sections, and patient-facing labelling, translated from English to Hindi and Marathi. The submission was accepted without any language-related queries from the regulatory authority.
All linguists on the project signed project-specific NDAs. The client has continued to work with us on subsequent submissions.
Our 5,000+ verified professional linguists include dedicated pharma and life sciences specialists with experience across regulatory, clinical, and quality documentation. Our 98% customer satisfaction rate reflects the consistency and precision that pharmaceutical clients in particular require.
For certified translations of individual pharmaceutical documents, see our certified translation services. For documents that need to be filed with courts or used in regulatory proceedings, we also provide certification on agency letterhead with a notarised affidavit.
A structured, documented process from project brief to final delivery.
Share your pharma documents and brief via email or WhatsApp. We assess the scope, subject area, regulatory authority, and target language before confirming the team and timeline.
A project-specific NDA is signed before work begins. If you have an approved terminology list, we load it. If not, we build one and share it for your approval before translation starts.
A pharma-domain linguist translates. A second linguist reviews for accuracy, terminology consistency, and regulatory language. A senior review pass is added for high-sensitivity submissions.
Final files are delivered in the format you need: editable Word, PDF, or in original DTP layout. Where certification is required, we provide a notarised affidavit and agency letterhead certificate.
We cover 120+ languages for pharmaceutical projects. The pairs most in demand for pharma regulatory and clinical work are listed below.
Not seeing your language pair? We cover 120+ languages and 900+ language pairs. Contact us to confirm availability.
What separates specialist pharmaceutical translation from general translation services.
No general translators on pharmaceutical projects. Every linguist assigned holds subject-matter expertise in life sciences, pharmaceutical science, or a related clinical discipline. They know ICH terminology, GCP language, and the controlled vocabularies that regulators expect.
Every pharmaceutical project begins with a project-specific NDA signed before any document is accessed. No public cloud storage. Restricted access to named team members only. Confidentiality is not an optional add-on. It is a structural requirement of how we work.
Regulatory submission deadlines do not move. We commit only to timelines we can deliver. Our capacity of up to 50,000 words per day means large dossier projects can be completed without compromising accuracy. We have not missed a committed delivery date on a regulatory submission.
We hold dual ISO certification: ISO 17100:2015, the international standard for translation services, and ISO 9001:2015 for quality management systems. These certifications meet the vendor qualification requirements of pharmaceutical procurement and quality assurance departments.
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.
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.
Answers to the questions pharmaceutical clients most commonly ask us before engaging.
Yes. Wordsmith Language Solutions has worked with pharmaceutical companies since 2013, translating regulatory submissions for CDSCO, EMA, and PMDA, as well as clinical trial documents, SOPs, and product labelling. Our linguists hold domain expertise in pharmaceutical and life sciences terminology, not only language proficiency.
We translate regulatory dossiers, clinical trial protocols, informed consent forms, investigator brochures, package inserts, product monographs, SOPs, batch records, audit reports, pharmacovigilance documents, drug master files, and marketing authorisation applications. We cover both regulatory and operational pharma documentation across the product lifecycle.
We assign only pharma-domain linguists to pharmaceutical projects. These are translators with academic or professional backgrounds in pharmacy, biochemistry, or life sciences, who translate pharma documents regularly. They understand ICH guidelines, GCP, GMP, and the regulatory language required by authorities such as CDSCO, EMA, and PMDA.
We cover 120+ languages for pharmaceutical translation. Languages most in demand for pharma include German, French, Japanese, Spanish, Italian, and Marathi and Hindi for CDSCO submissions. For EU regulatory dossiers and Japanese PMDA submissions, we have dedicated specialist teams with relevant regulatory experience.
Yes. We have experience translating documents for submissions to India's Central Drugs Standard Control Organisation (CDSCO), including dossiers, labelling, and patient information leaflets. Translations are certified on agency letterhead where required, with a notarised affidavit, and are accepted in the formats CDSCO requires.
All clinical trial translation projects are covered by a project-specific NDA signed before work begins. Documents are handled in a secure workflow with access restricted to the assigned linguist and project manager only. We do not use public cloud storage for confidential pharma documents. Confidentiality is treated as a non-negotiable requirement, not an optional service.
Turnaround depends on volume and document type. Standard turnaround for regulatory documents is 3 to 5 business days. For urgent submissions, we can mobilise a team to deliver up to 50,000 words per day without compromising accuracy. We discuss delivery timelines before every project and commit only to what we can deliver.
Yes. Our translations have been accepted by CDSCO in India, the EMA for European submissions, and PMDA for Japan. We follow the formatting and certification requirements of the relevant authority for each project. Where a certified translation is required, we provide it on agency letterhead with a notarised affidavit confirming accuracy.
