Translation Services for the Life Science Industry
When it comes to selling your products and services worldwide, you need a translation and localization partner you can trust. Seprotec has years of experience in providing solutions for the life science industry and is familiar with all relevant process requirements and legal regulations.
Thanks to our large team of industry experts, we cover a wide range of medical and pharmaceutical fields such as pharmaceutical and biotechnology, medical device, chemical and healthcare.
Seprotec offers comprehensive, high-quality solutions to facilitate multilingual communication in this crucial sector, from technical document translation to conference interpreting and patent translations and filings. We use state-of-the-art language technology and AI to help our clients achieve their ambitious content goals and meet their deadlines in a cost-efficient way.
Our management system is certified for quality translation according to the standards ISO 9001, ISO 17100, and ISO 13485, specific to medical devices. Our loyal customer base, which includes many pharmaceutical companies, research institutions, medical device manufacturers, and regulatory agencies, is proof of our commitment to the strictest confidentiality and security of information in any type of life science document.
Thanks to our large team of industry experts, we cover a wide range of medical and pharmaceutical fields such as pharmaceutical and biotechnology, medical device, chemical and healthcare.
Seprotec offers comprehensive, high-quality solutions to facilitate multilingual communication in this crucial sector, from technical document translation to conference interpreting and patent translations and filings. We use state-of-the-art language technology and AI to help our clients achieve their ambitious content goals and meet their deadlines in a cost-efficient way.
Our management system is certified for quality translation according to the standards ISO 9001, ISO 17100, and ISO 13485, specific to medical devices. Our loyal customer base, which includes many pharmaceutical companies, research institutions, medical device manufacturers, and regulatory agencies, is proof of our commitment to the strictest confidentiality and security of information in any type of life science document.
Life Science Translators
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Our approved translators for the life sciences sector are both native speakers of the target language and have a recognized qualification in translation or an equivalent degree in the medical and/or chemical domain in addition to at least 5 years of experience in translation in the relevant therapeutic field.
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They specialize in translating complex scientific materials for use by pharmaceutical companies, academic institutions, and other organizations. The qualification of the resources approved by Seprotec far exceeds the requirements demanded by the ISO 17100 standard.
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Seprotec professionals are carefully qualified by our resource management department and are required to complete a test translation and at least 10 supervised and evaluated projects before being approved.
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Translators, revisers, and project managers are selected based on their specialization and experience, ensuring technical precision and readability of the texts that account for local language and cultural preference.
Why Choose Seprotec?
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Accuracy above all Accurate medical translations are extremely important as people’s lives may depend on the exact meaning of a word. Our life science translators have proven experience in the subject matter and their work is backed by a solid quality assurance process.
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Quality assurance Our team of industry experts is committed to providing high-quality language services. With clearly defined and audited quality control processes at both a linguistic and technical level, we can ensure quality in the long term. We ensure accurate medical translations in line with the regulatory requirements.
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Data privacy and security As part of our strict information security strategy, we have implemented technical and procedural measures throughout the translation supply chain compliant with ISO 27001 and relevant data privacy regulations. This ensures that your data is safe from outside risks.
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On-time delivery Our committed team is prepared to assist you, even at short notice. Leveraging advanced translation and AI-empowered technologies, along with our extensive network of language experts, we guarantee prompt turnaround times for your time-sensitive projects.
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Comprehensive language services Get access to a wide range of language solutions designed specifically for the life science and medical sectors, such as interpretation, localization, sworn and certified translation, patent translation and global filing, document translation, and cultural consultation, all provided by professionals in the field.
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Loyal client base We build long-term relationships based on trust and satisfaction by consistently delivering high-quality translation, interpreting, and IP solutions. We proudly serve our clients worldwide, including young innovative startups and leading multinational organizations within the life science and medical sectors.
Areas of Expertise Within the Life Sciences Industry
In the life sciences sector, knowing the specific sub-industry industries and the regulatory requirements is crucial. Our dedication to quality and experience in the sector makes us a reliable partner that propels advancements in the life sciences.
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Pharmaceutical & biotechnology
Getting a drug on the market is an extensive procedure. From clinical research to marketing, translations are essential at every stage. Seprotec has provided clients with high-quality translation services that minimize risk and comply with regulations for years. Our professional translation and localization services assist businesses worldwide by providing regulatory compliance, document translation, interpreting, website localization, patent translation, international filing, and more.
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Medical technology
Seprotec provides customized language solutions for the medical device industry, ensuring precise translations of software, directions for use, device descriptions and instructions, datasheets, labeling, and packaging. We ease market access and compliance with our deep understanding of industry norms and regulations like the US FDA’s Code of Federal Regulations (CFR) or the EU’s Medical Device Regulation (MDR). We make sure that medical device companies have access to content translated by qualified medical language experts in multiple languages, backed by stringent regulatory requirements.
Seprotec has implemented strict quality procedures, including ISO 13485 certification, ensuring that medical device manufacturers can rely on consistent translation quality, regulatory compliance, and effective risk management. This, in turn, contributes to the safety and success of their products in the market. -
Clinical trials
Seprotec specializes in language solutions for clinical trials, offering precise translations of crucial papers such as consent forms, study protocols, ICFs, CRFs, patient questionnaires, safety reports, PROs, ePROs, QoL surveys, and COAs. Our language and subject-matter experts support the accuracy, confidentiality, and compliance of your trials by facilitating multilingual investigator meetings, and regulatory inspections by incorporating linguistic validation into the translation workflow. With the right translation company on board, you can ensure that all medical and life science documents are compliant with global clinical trials and regulatory requirements.
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Healthcare organizations
Healthcare organizations are an essential area of expertise that calls for a thorough grasp of legal standards and medical jargon. Accurate translation services are crucial for effectively connecting with patients and healthcare professionals. This involves interpreting adverse event reports and informed consent forms.
Due to the negative impact of inaccurate content on patients, medical translation services demand subject matter experts who know the best translation techniques; they go beyond simple language conversion of scientific literature.
Highlighted Services for the Life Science Industry
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Frequently Asked Questions
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What does a life science translation cost?
The cost of medical translation can vary depending on the language combination, the subject area, the quality requirements, and the translation process. The basis for pricing is usually a price per source word. There are also pricing models, though, in which costs are calculated per line/page or hourly rate.
If translations are required frequently, the use of Computer-Assisted Translation (CAT) tools can further lead to long-term reductions in translation costs. These tools create and maintain a translation memory (TM) with every translation carried out and can also recognize repetitions within the text. If you would like to find out the price for a specific document, please contact us, and we will provide you with a free, non-binding quote. -
What qualifications do medical translators have?
Our approved translators are native speakers of the target language and have a recognized qualification in translation or equivalent degree in the medical and/or chemical domain. They also have at least 5 years of experience in translation in the relevant therapeutic field.
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What is the Medical Device Regulation (MDR) and why is it so important?
The Medical Device Regulation (MDR) came into effect in May 2021. It outlines requirements for manufacturers to sell their products in the EU, including the requirement that relevant product safety documents be translated into the language of the target market. Similar regulations, like the FDA in the US, exist globally, necessitating translations for international businesses in the medical technology sector.
These regulations demonstrate how translation becomes a fundamental part of the medical equipment lifecycle, including marketing materials, user manuals, and labeling.
The role of translation service providers in navigating the new MDR regulations cannot be overstated. ISO 13485 compliance further ensures translations that are inherently compliant with MDR standards, offering assurance to manufacturers and service providers.
Seprotec prioritizes high-quality translations and traceability in all processes, making ISO certifications mandatory. -
What is ISO 13485?
The standard ISO 13485 describes the requirements of a quality management system used by medical device manufacturers, importers, and distributors.
This standard is aimed not just at medical device manufacturers but also at the suppliers with whom they interact throughout the device’s lifecycle. Translation becomes associated with the medical device as soon as it is exported to other countries, with the need arising to translate its labeling, user instructions, and other marketing materials, to give just a few examples.
Seprotec, a supplier to medical technology manufacturers, has integrated ISO 13485 into its quality management system, demonstrating its commitment to quality in the medical technology sector. -
Why is ISO 13485 important for Medical Devices translation services?
This ISO 13485 standard effectively covers the quality processes that must be followed with clients from the medical and diagnostic device industries, as well as the hospital and dental clinic supply industry. It is a system guaranteed by the rigors of an independent external audit, and it focuses on important topics such as safety and excellence—both of which are of particular relevance in the medical industry. If you want to learn more about quality standards, click here.
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