Specialised translation for pharma, medical devices and clinical trials
Request a Free QuoteThe pharmaceutical industry operates in a strict regulatory environment where every word counts. An incorrect translation in a package leaflet, a clinical trial protocol or a registration dossier can delay regulatory approval, compromise patient safety or generate significant legal costs. M21Global provides pharmaceutical translation with native translators specialised in life sciences, ensuring terminological accuracy and regulatory compliance.
We work with pharmaceutical laboratories, CROs (Contract Research Organisations), medical device manufacturers and biotech companies across more than 30 language combinations. With ISO 17100 certification and continuous improvement processes, every project undergoes rigorous documentary quality control, adapted to the requirements of regulators such as the EMA, FDA, ANVISA and national agencies worldwide.
Pharmaceutical translation encompasses a vast spectrum of technical and regulatory documents, each with specific terminology, formatting and compliance requirements. At M21Global, we translate the entire documentary chain across a medicine or medical device's lifecycle:
Registration dossiers (CTD/eCTD): modules 1 to 5 of the Common Technical Document, including product summaries, quality data, non-clinical and clinical studies. These dossiers are submitted to regulators such as the EMA (European Medicines Agency), the FDA in the United States, ANVISA in Brazil and national agencies worldwide. They demand absolute precision in pharmacological terminology and cross-references between modules.
Package leaflets (PIL/SmPC): the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) are regulated documents accompanying every medicine. We translate these respecting the EMA's QRD templates and the terminological conventions of each target market, ensuring that therapeutic indications, dosage, contraindications and side effects are communicated with clarity and rigour.
Clinical trial protocols: protocols, synopses, protocol amendments, Case Report Forms (CRFs) and safety reports (SAR/SUSAR). Medical and scientific translation of these documents requires deep knowledge of clinical methodology and MedDRA terminology.
Informed Consent Forms (ICF): documents that must be comprehensible to lay participants in clinical trials, balancing scientific rigour with linguistic clarity. A translation that the patient does not understand can invalidate consent and compromise the entire trial.
Pharmacovigilance: Periodic Safety Update Reports (PSUR/PBRER), adverse reaction notifications and Risk Management Plans (RMP). These documents have strict regulatory deadlines — delays can result in penalties or suspension of marketing authorisations.
Medical devices: Instructions for Use (IFU), CE declarations of conformity, technical documentation for CE marking under Regulation (EU) 2017/745 (MDR), and safety data sheets. Technical translation of these documents requires mastery of biomedical engineering terminology.
Regulatory and marketing material: generic registration dossiers, correspondence with regulatory authorities, promotional material subject to regulatory approval (which must respect the approved SmPC), and technology transfer documentation between manufacturing sites.
In the pharmaceutical industry, translation is not merely a linguistic matter — it is a regulatory one. An incorrectly translated term can alter the clinical meaning of an indication, cause medication errors or delay the approval of a medicine in a new market. M21Global implements a rigorous terminological system that ensures compliance from the very first project.
ICH Guidelines: we follow the International Council for Harmonisation (ICH) guidelines, namely ICH E6 (GCP — Good Clinical Practice), ICH E2 (pharmacovigilance) and ICH M4 (CTD). Our translators know the structure and terminology of these documents, ensuring that translations respect the conventions established by regulators.
MedDRA terminology: the Medical Dictionary for Regulatory Activities (MedDRA) is the terminological standard for communicating adverse reactions and medical events. We use the latest MedDRA version in the working languages, ensuring that reported terms are consistent with those used by regulators and pharmacovigilance databases.
INN nomenclature: active substance names follow the WHO's INN (International Nonproprietary Names) system. We systematically verify that INNs are used correctly in the target language, avoiding confusion with trade names or with similar substances' INNs.
Client-approved glossaries: each pharmaceutical client has specific terminological preferences — product names, formulations, devices, internal procedures. We create and maintain dedicated glossaries per client and per project, validated by the client's regulatory team before translation begins. These glossaries are integrated into our translation tools so they are applied automatically, reducing inconsistencies and accelerating reviews.
Our pharmaceutical translators have backgrounds in pharmaceutical sciences, biomedicine or related fields — they are not generalists translating medical texts. This specialisation, combined with ISO 17100 certification, ensures that every translation meets regulatory requirements from the first delivery.
Pharmaceutical translation demands more than linguistic competence — it requires auditable processes, traceability and documentary quality assurance. M21Global operates with two ISO certifications that directly address the industry's needs:
ISO 17100 (Translation Services): this standard defines requirements for the translation process, including translator and reviewer qualifications, documented workflows, project management and client feedback. In practice, it means every pharmaceutical translation follows a TEP process (Translation, Editing and Proofreading) with mandatory role separation: the translator and reviewer are always different professionals, eliminating self-review bias. Learn more on our ISO certification page.
ISO 18587 (Post-Editing of Machine Translation): for high-volume projects where machine translation can accelerate the process — such as knowledge bases, technical support FAQs or lower-criticality internal documentation — we use post-editing according to ISO 18587. This standard ensures that MT output is reviewed and corrected by qualified post-editors, assuring human-level quality in the final result.
Translator qualifications: translators working on our pharmaceutical projects hold degrees in life sciences (pharmacy, biology, medicine, biomedical engineering) or in translation with specialisation in health sciences. Each professional is assessed before joining the team and monitored through M21Global's continuous evaluation programme.
Confidentiality and data protection: pharmaceutical documentation contains commercially sensitive information and personal data from clinical trial participants. We operate with project-specific NDAs, need-to-know access restrictions, encrypted connections and limited data retention. We follow GDPR principles for the protection of personal data and intellectual property.
Clinical trials are the heart of pharmaceutical development — and they generate massive volumes of documentation that must be translated accurately within strict regulatory timelines. M21Global has proven experience in translating all documentation associated with multicentre, multi-country clinical trials.
Protocols and synopses: clinical protocol translation is often the first step in a multi-country trial. We translate the complete protocol, including objectives, inclusion/exclusion criteria, primary and secondary endpoints, and the statistical plan. Each term is verified against the sponsor-approved glossary and MedDRA conventions.
CRFs (Case Report Forms): data collection forms must be translated with extreme care — a mistranslated field can generate incomparable data between research centres in different countries. We translate electronic and paper CRFs, preserving field structure and completion instructions.
ICFs (Informed Consent Forms): informed consent must be comprehensible to lay participants without sacrificing scientific rigour. We adapt language to the target audience of each country, respecting local ethics committee requirements and ICH-GCP guidelines. A translation the participant does not understand can invalidate consent and jeopardise the entire study.
Safety reports: serious adverse reaction notifications (SAR/SUSAR), periodic safety reports (DSUR) and urgent safety communications (DHPC). These documents have defined regulatory deadlines — 7 days for fatal SUSARs, 15 days for non-fatal SUSARs — and translation must meet these timelines without compromising quality.
Regulatory deadlines: submissions to the EMA, FDA and other national authorities have deadlines that cannot be missed. M21Global manages regulatory timelines as part of project planning, ensuring that technical translation is delivered with sufficient margin for the sponsor's internal review before submission.
Multi-country trials: trials conducted across multiple countries require simultaneous translations into several languages with harmonised terminology. We coordinate parallel teams of native translators, using centralised glossaries and shared translation memories to ensure consistency across languages and research centres.
The relationship between a pharmaceutical company and its translation provider is a long-term partnership, not a one-off transaction. Pharmaceutical projects involve complex terminology that evolves throughout the product lifecycle, regulatory deadlines that admit no delays, and confidentiality requirements that demand mutual trust. M21Global structures this relationship around five pillars:
1. Initial briefing — regulatory and terminological analysis: before starting any translation, we conduct a detailed briefing with the client to understand the regulatory context (target market, regulator, submission type), preferred terminology (existing glossaries, style guides), delivery formats and deadlines. This briefing prevents rework and aligns expectations from the first project.
2. Dedicated team per account: we assign a fixed team of translators and reviewers to each pharmaceutical client. This continuity ensures that the professionals know the client's terminology, preferred style and product idiosyncrasies — without the need for re-briefing with each project. The team is coordinated by a dedicated project manager who serves as single point of contact.
3. Translation memories and term bases per client: each client has their own TMs (Translation Memories) and TBs (Term Bases), built project after project. This guarantees three things: terminological consistency over time, cost reduction for repeated content (previously translated segments are reused), and faster delivery timelines. Linguistic assets belong to the client.
4. Specialist sector review: beyond standard linguistic review (TEP), pharmaceutical projects include additional review by a specialist with training in the field — pharmacy, medicine, regulatory affairs. This reviewer validates not only linguistic correctness but terminological adequacy for the regulatory and clinical context.
5. Regulatory deadline management: we integrate regulatory deadlines into project planning, ensuring deliveries are made with sufficient margin for the client's internal review before submission. For urgent submissions, we mobilise additional resources without compromising quality. Request your quote and discuss your project timelines with our team.
We translate the entire pharmaceutical documentary chain: CTD/eCTD registration dossiers, package leaflets (PIL/SmPC), clinical trial protocols, Informed Consent Forms (ICF), pharmacovigilance reports (PSUR/PBRER/DSUR), medical device Instructions for Use (IFU), CE marking documentation (MDR), regulatory material for submission to entities such as the EMA, FDA and ANVISA. See our medical and scientific translation page for more details.
Yes. Translators working on our pharmaceutical projects hold degrees in life sciences — pharmacy, biology, medicine, biomedical engineering — or in translation with specialisation in health sciences. We do not assign pharmaceutical documentation to generalist translators. Each professional is assessed before joining the team and monitored through our continuous evaluation programme, which tracks quality metrics, terminological accuracy and deadline compliance.
Yes. We have documented experience with regulatory deadlines from entities such as the EMA, FDA and ANVISA. We integrate regulatory deadlines into project planning, ensuring deliveries are made with sufficient margin for the sponsor's internal review before submission. For critical deadlines — such as SUSAR notifications (7-15 days) or type II variations — we mobilise additional resources without compromising quality. Our ISO 17100 certification guarantees documented and reproducible processes even under pressure.
Yes. We translate regulatory documentation for submission to ANVISA (Brazil's National Health Surveillance Agency), including registration dossiers, bulas (the Brazilian equivalent of package leaflets), bioequivalence studies and medical device documentation. We work with native Brazilian Portuguese translators with life sciences backgrounds, ensuring Brazilian regulatory terminology and conventions are respected. This service is particularly relevant for European laboratories seeking to register medicines or devices in the Brazilian market.
Through three integrated mechanisms: dedicated translation memories (TM) per client, which store all previously translated segments and apply them automatically in new projects; term bases (TB) validated by the client's regulatory team, ensuring that approved terms are used consistently; and dedicated teams per account, where the same translators and reviewers work on the same client's projects over time, accumulating knowledge of the terminology, style and specific preferences. This model ensures that quality and consistency improve project after project.
Solicite um orçamento gratuito e receba uma resposta personalizada em menos de 3 horas.
Request a Free QuotePlease visit this page before submitting your documentation.
