Thanks to ever expanding regulatory requirements handed down by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and Japan’s Ministry of Health, Labor and Welfare (MHLW), pharmaceutical companies are finding it increasingly difficult to pursue and compete in developing global markets. The EMEA alone requires labeling documents to be completed in 23 languages.
Challenges include revising production processes, satisfying evolving product labeling and instructions regulations, meeting industry standards and complying with new formatting requirements such as the FDA’s 21 CFR Part II governing electronic records and Structured Product Labeling (SPL), requiring labeling in XML format.
Companies must also contend with a broad range of language translation requirements.
The tools for effective pharmaceutical language translation
viaLanguage employs a unique Online Language System (OLS) , its signature Four-Phase Methodology and a host of complementary translation services to help you achieve smoother, quicker language translation and get to market faster. viaLanguage translation services include:
Contact us for a free pharmaceutical language translation quote.
“As the translation service department for BASF, we often require the assistance of external colleagues. As a rule, our projects are terminologically difficult, urgent and confidential representing various domains of applied chemistry, including the manufacture of raw materials for the pharmaceutical industry. We work with viaLanguage because of their secure, ‘round the clock electronic ordering system, impressive number of languages and high quality translations customized to our technological needs.”