In the pharmaceutical industry, inaccurate translation is a liability your organization cannot afford. From regulatory delays to patient safety risks and severe legal consequences, the cost of a single error is too high. Language Scientific provides the precision and regulatory expertise required to protect your global clinical trials and product launches.
Language Scientific specializes in scientific and medical translation, with doctors and scientists bringing subject-matter expertise directly to the work. Our LS Certified methodology provides expert review and certification for manual, AI-assisted, and AI-generated translations, helping maintain medical accuracy and reduce risks associated with pharmaceutical documentation.
Our clients in the pharmaceutical industry include Fortune 100 multinationals such as Merck, Novartis, Stryker, and Pfizer. We also work with small and midsize, rapidly globalizing technology and biopharmaceutical companies like Amgen, Mettler-Toledo, Emergo Group, and Tektronix.
Language Scientific manages the entire translation process so you can focus on developing life-saving drugs on an expedited basis. Our expertise covers over 215 global languages for the industry’s most critical documents:
Under 21 CFR 314.50(g)(2), the FDA requires accurate and complete English translations of any portions of a New Drug Application (NDA) that aren't in English. Applicants must also provide copies of original literature publications submitted with English translations.
For centrally authorized medicines, the European Medicines Agency (EMA) has a formal linguistic review process for product information, including summaries of product characteristics, labeling, and package leaflets. Depending on the procedure, this involves reviewing English product information and translations into other required languages.
For initial centralized marketing authorization applications and line extensions, EMA guidance calls for product information translations within five days of a positive CHMP opinion (Day 215 in the standard procedure). Because requirements and review schedules vary by procedure, translation planning should begin well before the final submission deadline.
No. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) states that marketing approval application forms must be submitted in Japanese. Pharmaceutical companies preparing submissions for Japan need to account for Japanese-language documentation requirements as part of their regulatory planning.
Yes. The EMA specifically identifies poor-quality translations and incomplete implementation of linguistic review comments as issues that can delay the transmission of product information to the European Commission. Accurate terminology, consistency, and timely revisions are therefore important considerations during regulatory translation.
No. Reporting requirements depend on the event and the applicable regulations. A suspected unexpected serious adverse reaction (SUSAR) involves a serious reaction that is unexpected and has a suspected causal relationship to the investigational medicinal product. Sponsors must assess whether an event meets the criteria for expedited reporting.
Under 21 CFR 312.32, qualifying serious risks generally must be reported as soon as possible, no later than 15 calendar days after the sponsor determines that the information is reportable. Unexpected fatal or life-threatening suspected adverse reactions must be reported to the FDA as soon as possible, no later than seven calendar days after the sponsor initially receives the information.
Under Regulation (EU) No 536/2014, sponsors must report fatal or life-threatening SUSARs as soon as possible, within seven days of becoming aware of the reaction. The deadline for non-fatal or non-life-threatening SUSARs is 15 days. Additional follow-up reporting requirements may apply.
No. Expedited SUSAR reporting and periodic safety reporting serve different purposes. Under Article 43 of the EU Clinical Trials Regulation, sponsors submit annual safety reports for investigational medicinal products other than placebos. ICH E2F establishes the Development Safety Update Report (DSUR) format for periodic safety reporting. These reports assess the developing safety profile of a product rather than reporting individual reactions under expedited SUSAR deadlines.
The reporting obligation remains with the sponsor, and the applicable deadline depends on the authority, report type, and triggering event. For time-sensitive safety documentation, translation requirements should be identified early enough to allow for medical terminology review, accuracy checks, and submission preparation within the applicable reporting window.
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