MEDICAL TRANSLATION

Clinical Trials

Accurate. Compliant. Trusted by leaders in pharma.

We provide expert medical translation services in full compliance with EMA and FDA regulatory requirements, ensuring every document meets the highest standards of accuracy and terminology consistency.

Our services follow the ISO 17100:2015 standard for translation quality, with multi-step workflows including native-speaking medical linguists, editing, proofreading, and rigorous in-house quality control.

With over 1 million words translated in the field of clinical trials, our experience includes work with:

End clients: Pfizer, Syneos Health, IQVIA, Servier, Dr. Reddy’s Laboratories

Types of documents:

• Summary of Product Characteristics (SmPC) (Accurate rendering of legally binding pharmacological data across multiple EU languages, ensuring alignment with EMA QRD templates and national regulatory agency requirements.)

• Informed Consent Forms (ICF) & Patient-Facing Materials (Culturally sensitive and legally compliant translations tailored for ethics committee approval, with back-translation and reconciliation workflows as required for high-risk trials.)

• Clinical Study Protocols & Investigator’s Brochures (Complex multi-layered content translated for submission to institutional review boards (IRBs), ensuring consistency with study design, endpoints, inclusion/exclusion criteria, and investigational product data.)

• Risk Management Plans (RMP) & Pharmacovigilance Reports (Translated in accordance with EMA’s GVP Module V, with full retention of technical terminology and regulatory phrasing for post-marketing risk minimization strategies.)

• Regulatory Submissions (EMA & FDA) (Translation of core dossier components for centralized and decentralized procedures, including cover letters, responses to authorities, labeling components, and safety updates (PSUR, DSUR).)

Our translations support clinical trial workflows at every stage - from research and development to post-marketing surveillance - ensuring clarity, compliance, and patient safety across languages.



Medical Devices

Precise translations for high-risk content - compliant, consistent, and expert-driven.

We provide specialized translation services for the medical device industry, operating within international regulatory frameworks such as the EU Medical Device Regulation (MDR) and FDA standards.

Our linguists hold medical degrees and possess hands-on experience with clinical and technical documentation, ensuring that each translation is not only linguistically accurate but medically and technically sound.

We work strictly in accordance with ISO 13485 and ISO 17100 standards, applying a multi-step quality assurance process that includes medical review, terminology verification, and consistency checks - especially critical for high-risk content like surgical devices, implantables, or diagnostic equipment.

Currently, we collaborate with companies in the medical device sector, including:

• AGFA HealthCare (Medical Imaging Systems - Translated complete user interfaces, DICOM protocols, operator manuals, radiological image acquisition guides, system configuration files, and service documentation for diagnostic imaging platforms used in hospital PACS/RIS systems. All materials were localized in line with MDR and IEC 62366 requirements for usability in healthcare environments.)

• Cook Medical (Coronary Artery Stents & Endovascular Devices - Provided multilingual translations of Instructions for Use (IFU), sterilization and packaging validation reports, surgical technique guides, and regulatory submissions for balloon-expandable stents, catheter delivery systems, and vascular access tools. Content complied with FDA 21 CFR Part 820 and EU MDR annexes.)

• BHM Medical (Reproductive Health & Prenatal Monitoring Devices - Translated user manuals, clinical study protocols, performance testing reports, and patient-facing materials for fetal heart monitors, maternal wearable sensors, and non-invasive diagnostic tools used in obstetrics. Ensured consistency with ISO 14155 and usability requirements under EU MDR.)

• VivoVitro (Assisted Reproduction Laboratory Technologies - Localized product documentation for IVF systems, embryo culture chambers, cryopreservation devices, and gamete manipulation tools. Translations included CE technical files, protocols for embryologists, labeling, software UI, and compliance reports aligned with ISO 13485 and applicable EU directives.)

Document types we work with:

• Market access dossiers (CE / FDA)

• Instructions for Use (IFUs)

• User manuals Sterilization and testing reports

• Clinical protocols

• Product labeling

• Declarations of Conformity

• Risk management documentation

Every document we translate supports device safety, usability, and successful global market entry.

Medical Documentation

Confidential medical translations for informed decisions and safe treatment.

We provide precise, confidential medical translations not only for corporate clients but also for individuals and patients, supporting healthcare access, second opinions, and cross-border treatment.

All translations are performed in strict compliance with ISO 17100 and ISO 27001 standards, ensuring both linguistic accuracy and data confidentiality at every stage.

We translate:

• Diagnostic reports (Ultrasound, CT, ECG, endoscopic findings, functional assessments - including detailed descriptions of detected abnormalities and physician interpretations.)

• MRI interpretations (Comprehensive readings of magnetic resonance scans, including lesion localization, neurological assessments, and radiologist conclusions.)

• Medical conclusions & discharge summaries (Structured clinical overviews issued post-treatment or hospitalization, covering diagnosis, treatment provided, follow-up recommendations, and prognosis.)

• Medical histories & anamneses (Patient background records containing chronic conditions, prior interventions, allergies, lifestyle factors, and familial predispositions - essential for continuity of care.)

• Laboratory test results (Detailed blood panels, pathology results, hormonal profiles, infection markers, and other diagnostic metrics, with units and reference ranges preserved and clarified.)

• Diagnoses & clinical evaluations (Formal diagnostic statements from physicians, often required for insurance claims, visa applications, or referral purposes - rendered with absolute terminological precision.)

We understand the sensitive nature of personal medical records. All documents are handled by medical translators bound by confidentiality agreements, with secure file processing and traceable quality assurance at each step.

Whether you’re a hospital, law firm, insurance provider, or an individual seeking treatment abroad - your medical documentation is in safe hands.

Pharma

Language solutions for the entire pharma lifecycle

We provide high-precision translation services for the pharmaceutical industry, covering the full lifecycle of medicinal products - from pre-approval documentation to post-marketing compliance. Our work strictly follows EMA and FDA regulatory frameworks and complies with ISO 17100 and ISO 13485 standards.

Whether you are submitting a new drug application, updating a product’s labeling, or localizing manufacturing documentation, we ensure every term and phrase is scientifically accurate, regulatory-aligned, and ready for inspection.

Our translation experience includes:

• Regulatory Dossiers (CTD Modules 1–5) (Administrative documents, clinical and non-clinical summaries, and pharmaceutical quality documentation required for Marketing Authorization Applications.)

• Product Information & Labeling (Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labeling components structured according to QRD templates and national agency requirements.)

• Pharmacovigilance Documentation (Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), Individual Case Safety Reports (ICSR), and reports on Adverse Drug Reactions (ADR).)

• Manufacturing & GMP-related content (Standard Operating Procedures (SOPs), batch records, master manufacturing instructions, quality control protocols, stability testing reports, and Certificates of Analysis.)

• CMC Documentation (Chemistry, Manufacturing, and Controls) (Detailed descriptions of drug substance and product specifications, analytical methods, and validation data for regulatory compliance.)

• Marketing & Promotional Materials (Medical reps' brochures, mode-of-action infographics, product monographs, patient education content — with medical accuracy and local cultural adaptation.)

Our end clients include Pfizer, Sanofi, Novartis, Dr. Reddy’s Laboratories, Servier, and other global pharma leaders and CROs - all relying on our expertise for regulatory, CMC, and safety-related translations across international markets.

Each project undergoes terminology harmonization, regulatory review, and multi-level quality control to meet the strictest industry requirements.

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