Pharmaceuticals
We focus on the Quality and Accuracy of Pharmaceutical Translations
In the pharmaceutical industry, where the accuracy of translations has a direct effect on patients’ lives, accuracy and clarity has a large impact on a drug’s time-to-market and company reputation. As the world is setting higher standards for drug approvals, top global pharmaceutical enterprises are now turning to global language solutions in order to meet these demands.
EC Innovations has been working with many of today’s leading companies in pharmaceutical Industry for over 27 years. We comply with high quality standards to ensure accuracy and consistency in providing localization services to our clients while meeting tight deadlines.
Complete Translation Services for Pharmaceuticals
Our professional localization and translation services for the pharmaceutical industry include regulatory compliance document translation and Desktop Publishing, software and website, e-learning and multimedia localization:
- Summary of Product Characteristics (SmPCs)
- Labeling and Packaging
- Patient Information Leaflets (PILs)
- Patient Reported Outcomes（PROs）
- Medicines Summary
- Clinical Study Protocols
- Informed Consent Forms (ICFs)
- Patents and Patent Applications
- Website Content
- Training and Educational Documentation
The EC Innovations Difference
EC Innovations Life Sciences has been an established leader in medical device translation for over 27 years. What sets us apart from the rest?
Qualifications and Standard Compliance
EC Innovations Life Sciences holds ISO 13485:2016 and ISO 17100:2015 certification for the translation and localization of the accompanying content for biotech and medical devices.
EC Innovations Life Sciences complies with high quality standards of the life sciences sector to meet end user’s expectations and patient safety. We are especially honored to be Siemens’ Outstanding Language Service Provider since 2007.
Dedicated Life Sciences Division
With focus and commitment comes professionalism, EC Innovations Life Sciences is a division with more than 100 employees dedicated to serving only the life sciences industry.
Innovative technologies (TBMS LPA) make continuous delivery possible
We’ve been continuously refining our TBMS LPA system more than 15 years ago to fit the business trends and compliance needs of our medical device clients. Our proprietary technology enables the workflow automation for content transfer, file preparation, instant quotation, maintenance of language assets, KPI evaluation, data mining for decision making, translation quality report generation, among others. This allows us to shorten turnaround time and lower cost without compromising quality, and make continuous delivery an achievable solution. Refer to TBMS LPA for more information.
Project Team as the Cornerstone of Quality
Our translation team mainly comprises native speakers of the target language who take on the following roles:
- Subject-matter experts (SME): Possessing medical background with cumulative experience and knowledge in medical translation, our SMEs support terminology translation and maintenance as well as answer technical questions from translators.
- Qualified translators: Our translators undergo assessment based on our Translation Quality Report (TQR), and we try our best to assign translators to the same product line for the same client.
- Experienced editors: With years of experience in medical device translation, our editors are effective at using our cloud-based Computer-assisted Translation tool to review and make edits in real time to provide feedback and confirmation in the shortest time possible.
- Rigorous proofreaders: Equipped with background knowledge of related medical devices, they simulate end users by reviewing the translation with a fresh eye and without referencing source content.
- Quality Assurance reviewer: Our QA team will sample 10% to 20% of total translations to independently verify quality and identify potential quality issues.
- In-country reviewers or third-party reviewers: Often requested by clients to serve as a further guarantee of translation quality.
- In-country language leader: Work closely with our translator recruitment and management team to build tailored and dedicated translator teams for each client.
- Multilingual DTP team: Ensure that translated documents are compliant and ready to be published in the right format.
Deliver high quality translations for user safety
Most pharmaceutical materials in need of translation are intended for patients. Along with accuracy, translation clarity has the most direct impact on a drug’s marketing success.
To deliver high-quality pharmaceutical translations, the accuracy of terminology is crucial. Supported by our cloud-based Terminology Management System, our biotech and pharmaceutical Subject Matter Experts (SME) suggest translations for all terminology and our clients’ Terminology Experts approve the translations. The translated terminology is automatically displayed in the cloud-based Computer-assisted Translation System, and can be used online by translators, editors, proofreaders, and QA reviewers in a simple, easy-to-use interface. Terminology translation, approval, maintenance, and usage are seamlessly integrated into project’s entire life cycle, which maximizes the accuracy and consistency of the translation.
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Translations for repetitive content are saved in Translation Memory (TM) Database for reusing among document, website, marketing and training materials, which will ensure translation consistency and reduce costs to our clients. Furthermore, terminology translations can be synchronized between terminology database and Translation Memory (TM) Database with our technology. For any update in terminology database, such as adding of new terms or altered translations for existing terms, the system will automatically check against terminology translations in the TM and display all differences, while the administrator only needs to click one button to synchronize terminology translations in TM, with the option of manual confirmation.
In addition to translation, editing, proofreading and independent QA processes, in-country reviews or third-party reviews serve as a further guarantee of error-free translation quality.
The above measures ensure that consumers and patients easily understand pharmaceutical content, so they can make the right product choice and use products properly.
Making the most of a tight time frame
Timely delivery of pharmaceutical translations can be tricky; during the registration period, there are typically only a few days between approving the source document and submitting the various translations. EC Innovations’ language solutions can save time and decrease manual costs, which can leave time for our clients to check the translations carefully and submit before the deadline.
Translation accuracy and quality are also paramount, because a poor translation can result in extra delays in the QRD (Quality Review of Documents) process. EC Innovations has specialized, in-country pharmaceutical translators that provide linguistic review and validation, to save companies from major expenses and help them meet regulatory requirements—all while providing peace of mind.
EC Innovations is especially experienced in performing pharmaceutical regulatory compliance translation projects for clients looking to receive official approval from:
- The Food and Drug Administration (FDA)
- The European Medicines Agency (EMEA)
- The China Food and Drug Administration (NMPA)
- The Pharmaceuticals and Medical Devices Agency (PMDA)
- Other Countries
Pharmaceutical “Back Translations”
A “back translation” is to translate a document back into the source language after it was translated into the target language. Translation quality is evaluated by comparing the original language version and the “back translated” version. Such an approach can be a useful tool in improving a translation’s validity, accuracy, and readability. EC Innovations regularly fulfills requests for pharmaceutical back translations to deliver the highest quality for the purposes of regulatory compliance and to prevent erroneous information from target consumers and our clients’ patients.
Translation of FDA
New Drug Applications (NDA)
Our client’s previous language services provider was unable to meet its high-quality requirements and turnaround time expectations, which resulted in delayed submissions of new drug registrations and significantly increased workloads for internal review.
EC Innovations surpassed the client’s expectations by enabling timely deliveries and increased translation accuracy, in addition to a nearly 30% savings for the client. Download the success story to learn more about how we smoothly and successfully aided a leading pharmaceutical company’s New Drug Applications for the FDA.
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The Best Quality-to-Cost Ratio on the Market.
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