Pharmaceutical Translation Services
Language Solutions for the Pharma & MedTech Sectors
EuroMinds Linguistics specialises in pharmaceutical translation services, covering everything from research, clinical trials, and regulatory documents to marketing and training materials. We help pharmaceutical companies meet regulatory requirements and effectively market products in new territories. Accurate translations of patient leaflets, product labels, brochures, and legal contracts are vital to meeting standards, ensuring compliance, and expanding global reach within tight deadlines.
Two Pillars of Health: Medical Devices and Pharmaceuticals
While both the medical technology and pharmaceutical industries are pillars of modern healthcare, they operate in fundamentally different ways. Medical devices rely on proper usage, professional expertise, and clinical settings, with effectiveness influenced by external factors like training and infrastructure. In contrast, pharmaceuticals are chemically designed to interact with the body’s systems, producing predictable, measurable outcomes.
These differences highlight the need for specialised translation services tailored to each field. Whether it’s user manuals for medical devices or regulatory documents for pharmaceuticals, precision, compliance, and expertise are essential to ensure global healthcare safety and effectiveness.
Medical Device Translation Services
Translations for medical devices cover user manuals, labelling, and technical documentation. These translations must not only be linguistically accurate but also comply with local regulatory requirements. This demands both medical and technical expertise—qualities our skilled specialist translators bring to deliver precise and dependable translations.
As a global and tightly regulated industry, the medical device sector requires flawless and clear communication. We provide specialised translation services to ensure your documents comply with all regulations and uphold patient safety.
Our translators are well-versed in using medical databases. From user manuals to clinical trial documentation, we deliver translations that help drive your success in international markets. Trust our expertise to navigate complex global regulations and ensure your medical devices are accessible worldwide.
Pharmaceutical Translation Services
In the pharmaceutical sector, translation tasks include clinical studies, research reports, packaging information and regulatory submissions. As these documents directly affect the safety and efficacy of medicines, absolute precision is essential.
The pharmaceutical industry demands both accuracy and speed. Stringent regulations must be met, while getting products to market quickly is crucial to recoup R&D costs. At EuroMinds Linguistics, we are committed to understanding your unique needs and providing exceptional customer service.
We translate for biotherapeutics leaders, clinical research teams, regulatory affairs professionals, and pharma experts. Therefore, our team of specialised translators stays ahead of evolving regulations, ensuring your translated materials meet all compliance requirements.
Medical Device Regulation
The Medical Device Regulation (MDR 2017/745) became effective on May 25, 2017, and mandatory as of May 26, 2021, replacing the Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMD 90/385/EEC). The MDR introduces stricter requirements and expands the scope of medical device regulations, particularly regarding conformity assessments and CE labeling. Manufacturers must reassess their products for compliance, and responsibility for CE labeling rests with the person placing the product on the market. This means that operators may be considered manufacturers if they modify or assemble products independently.
Translation is crucial in this field to ensure regulatory documents, compliance guidelines, and technical specifications are accurately communicated across diverse languages and legal systems, maintaining global market access and compliance with regional laws.
Our Areas of Expertise Include:
Drug Labels and Package Inserts
Our team provides translations of detailed information about drug usage, dosage, side effects, and interactions, crucial for patient safety and compliance as well as patient information leaflets.
Pharmacological Studies
We translate research documents detailing the effects, mechanisms, and therapeutic potential of pharmaceutical compounds.
Registration Dossiers
Translation of registration dossiers to provide regulatory authorities with the required data to approve a drug or medical device and ensure compliance with regulatory requirements in the target market.
Regulatory Compliance Documents
Our language experts translate filings, submissions, and reports required by regulatory bodies to ensure compliance with industry standards.
Standard Operating Procedures (SOPs)
Our team translates detailed, step-by-step instructions for routine operations within laboratories, clinics, and manufacturing facilities.
Summary of Product Characteristics (SPC/SmPC)
Translation of SPCs that provide detailed information about drugs, including indications, dosage and side effects into foreign languages ensures healthcare professionals worldwide can access accurate drug information.