Translation of pharmaceutical documentation, medical devices, clinical trials and regulatory submissions. Native translators with health sciences backgrounds, ISO 17100 certified processes and compliance with EMA, INFARMED and FDA requirements.
Request a QuoteThe pharmaceutical and healthcare sector operates under one of the most demanding regulatory frameworks in the world. Every translated document, from a summary of product characteristics (SmPC) to an informed consent form (ICF), can have a direct impact on patient safety, drug approval or medical device compliance. When translation fails in this sector, the consequences go far beyond a poor user experience: they can mean regulatory delays, dossier rejections or risks to public health.
Most generalist translation providers do not have translators with health sciences backgrounds, are unfamiliar with the specific requirements of the EMA or INFARMED and lack processes adapted to regulatory documentation. The result is translations that require multiple rounds of correction by internal regulatory affairs teams, delaying critical timelines and consuming resources that should be focused on core business.
M21Medical is M21Global's specialised division for the pharmaceutical, medical devices and healthcare sector. We bring together specialised native translators with extensive medical and pharmaceutical translation experience, CAT tools with validated regulatory glossaries and ISO 17100 certified processes by Bureau Veritas. Over more than 20 years, we have translated documentation for clinical trials, regulatory submissions, pharmacovigilance and patient communications, always with the rigour this sector demands.
The healthcare sector has a highly specialised terminology that varies according to context: clinical terms, pharmacological nomenclature, ICD classifications, MedDRA terminology and vocabulary specific to each medical speciality. A generalist translator cannot navigate safely between these registers, and the risk of error is unacceptable when patient safety is at stake.
The M21Medical team is composed of specialised linguists with extensive translation experience in the pharmaceutical and healthcare sector. Each translator goes through a qualification process that includes practical tests with real regulatory documentation, assessment of MedDRA and ICH terminological knowledge, and validation of prior experience in the pharmaceutical or hospital sector.
M21Medical uses CAT tools configured specifically for medical and pharmaceutical documentation. Our translation memories and terminology databases are organised by therapeutic area, document type and client, ensuring terminological consistency throughout the entire lifecycle of a drug or medical device.
Automated quality control tools check compliance with regulatory glossaries, detect terminological inconsistencies between sections of the same document and validate the integrity of numbers, dosages and units of measurement before delivery. For clients with document management platforms, we offer direct integration with their systems.
Pharmaceutical and medical documentation contains highly sensitive information: unpublished clinical trial data, intellectual property of molecules in development, patient personal data and strategic commercial information. M21Medical operates with individual NDAs per project, file encryption in transit and at rest, and restricted access based on the principle of least privilege.
We comply with GDPR requirements, good documentation practice (GDocP) guidelines and ICH principles. Our processes are auditable and traceable, which facilitates demonstrating compliance during inspections by regulatory authorities such as the EMA, INFARMED or the FDA.
Translating pharmaceutical documentation requires deep knowledge of European and international regulatory formats. We translate summaries of product characteristics (SmPC), patient information leaflets (PIL), investigator's brochures (IB), investigational medicinal product dossiers (IMPD), expert reports and CTD (Common Technical Document) modules.
Each document type has specific format, terminology and style conventions that must be rigorously respected. M21Medical maintains up-to-date templates and glossaries for each format, ensuring that the translated documentation meets regulatory authority requirements without the need for reformatting by the client.
Translating clinical trial documentation is one of the most demanding areas of medical translation. Clinical protocols, informed consent forms (ICF), case report forms (CRF), clinical study reports (CSR) and communications with ethics committees require absolute precision and compliance with ICH-GCP guidelines.
M21Medical has proven experience in translating documentation for phase I to IV clinical trials, across multiple therapeutic areas. Our translators are familiar with the specific requirements of each national competent authority and work with the tight deadlines that are standard in this context, without compromising terminological rigour or regulatory compliance.
The Medical Devices Regulation (MDR 2017/745) introduced more stringent linguistic requirements for technical documentation, labelling and instructions for use (IFU) of medical devices marketed in the European Union. Translating this documentation requires knowledge of the regulatory framework, device classification and specific technical terminology.
M21Medical translates technical files, declarations of conformity, clinical evaluations, risk analyses, IFUs and documentation for notified bodies. Our translators understand MDR and IVDR requirements, ensuring that the translated documentation supports the CE marking process without delays.
Submissions to regulatory authorities such as the EMA, INFARMED or the FDA require documentation translated to the highest level of precision and compliance. A terminological error, an inconsistency between sections or incorrect formatting can result in requests for clarification that delay the approval of a drug or device.
M21Medical has experience translating marketing authorisation application (MAA) dossiers, variations, renewals, responses to regulatory authority questions and documentation for centralised, decentralised and mutual recognition procedures. We are familiar with the templates and conventions of each authority, ensuring compliance from the first submission.
Pharmacovigilance requires fast and accurate translation of documentation that is time-sensitive in regulatory terms. Adverse drug reaction reports (ADR), periodic safety update reports (PSUR), risk management plans (RMP), urgent safety notifications and direct healthcare professional communications (DHPC) have legal deadlines that cannot be exceeded.
M21Medical provides teams with priority response capacity for pharmacovigilance documentation. Our translators are familiar with MedDRA terminology, E2B formats and the reporting requirements of the EMA and national authorities, including INFARMED. We guarantee delivery within regulatory deadlines, without exception.
Patient communication requires a different approach from regulatory documentation. Patient information leaflets, informed consent forms, therapeutic education materials, device instructions for use and quality of life questionnaires must be translated in clear, accessible language that is culturally adapted to the target audience.
M21Medical applies health literacy principles in the translation of patient materials. Our translators balance medical accuracy with the clarity needed for patients without a scientific background to understand the information. When required, we perform back-translation and linguistic reconciliation to validate conceptual equivalence between versions.
Translating scientific articles, abstracts, posters, congress presentations and manuscripts for peer-reviewed journals requires mastery of scientific terminology and the editorial conventions of each publication. A poorly translated article can compromise the credibility of the researchers and the acceptance of the manuscript.
M21Medical translates and reviews medical and scientific publications across multiple therapeutic areas, including oncology, neurology, cardiology, immunology and infectious diseases. Our translators are familiar with ICMJE standards, the style requirements of major journals and the reporting conventions of CONSORT, STROBE and PRISMA.
Hospitals, clinics and healthcare networks with international activity require translation of clinical documentation, internal protocols, admission forms, medical reports, quality policies and training materials for healthcare professionals.
M21Medical translates hospital documentation with the terminological rigour appropriate to each speciality. Our translators understand the organisational structure of healthcare services, the clinical nomenclatures in use and hospital accreditation requirements, such as those of the Joint Commission International (JCI).
The labelling of medicines and medical devices is regulated by specific legislation in each market. The translation of labels, cartons, package leaflets and packaging materials must comply with strict requirements for space, format, terminology and regulatory compliance, including serialisation and safety feature requirements.
M21Medical works with artwork files in formats such as Adobe InDesign, Illustrator and PDF, ensuring that the translated text integrates into the existing layout without compromising legibility or compliance. We verify the accuracy of dosages, ATC codes, INN names, pictograms and mandatory warnings in each target market.
M21Medical combines more than 20 years of M21Global's experience in professional translation with deep specialisation in the pharmaceutical and healthcare sector. We are ISO 17100 certified by Bureau Veritas, which guarantees audited and traceable quality processes, aligned with the expectations of regulatory authorities.
Each project is assigned a dedicated manager and translators specialised in the relevant therapeutic area. We are not a generalist agency that also does medical translation: we are a team built specifically to meet the regulatory, terminological and confidentiality requirements of the healthcare sector.
Translation cannot be the bottleneck that delays the submission of a regulatory dossier or the start of a clinical trial. M21Medical integrates with the workflow of regulatory affairs and clinical operations teams, with processes designed to respect the sector's timelines.
We offer ongoing collaboration models for clients with regular volumes, with dedicated teams, shared glossaries and translation memories that evolve with each project. For one-off projects, we guarantee rapid onboarding and delivery within agreed deadlines. In both cases, communication is directly with the project manager, with no intermediaries.
Quality in medical translation is not measured only by the absence of errors: it is measured by compliance with regulatory requirements, terminological consistency throughout the entire dossier and the traceability of every translation decision. M21Medical uses MQM (Multidimensional Quality Metrics) to evaluate each delivery across dimensions such as accuracy, terminology, style and regulatory compliance.
Each project includes a quality report. Our ISO 17100 certification by Bureau Veritas means that all processes, from translator selection to final delivery, are audited annually. For clients who need compliance certificates for regulatory inspections, we issue supporting documentation on request.
Whether you are translating an informed consent form into 3 languages or a complete submission dossier for 25 European markets, M21Medical has the capacity to scale. Our network includes over 3,000 qualified translators in 95+ language pairs, with translators specialised in health sciences across all major regulatory markets.
For large-scale projects, such as simultaneous submissions to multiple authorities or translations of documentation for multicentre clinical trials, we assemble dedicated teams with centralised coordination. For smaller companies or biotech startups, we offer tailored solutions that guarantee the same level of regulatory rigour at costs proportional to the volume.
Processes certified by Bureau Veritas. Each translation is performed by a qualified translator and reviewed by a second independent linguist, as required by the standard.
more than 20 years of experience in the pharmaceutical and healthcare sector. Translators with extensive pharmaceutical and healthcare translation experience.
NDAs per project, file encryption, restricted access. GDPR compliance and good documentation practice (GDocP) guidelines.
Contractual commitment to delivery dates. Capacity for urgent pharmacovigilance and regulatory submission projects while maintaining quality standards.
All translators are native speakers of the target language and have proven translation experience in the pharmaceutical and healthcare sector.
Knowledge of EMA, INFARMED, FDA and other regulatory authority requirements. Up-to-date templates and glossaries for each type of submission.
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