We provide specialized translation and localization services to smooth the process of submitting marketing authorizations with the competent health authority.
The pharmaceutical & medical devices sector is one of the most regulated industries in the world. We’ve got the technical know-how and understanding to guarantee language regulations don’t interfere while obtaining authorization to market your products in foreign countries.
Language requirements
for Market Authorizations
In addition to language requirements, the European Medicines Agency (EMA) guidelines contain instructions on things such as font type and size, capitalization, the layout of information, syntax, style, and use of symbols.
It should be as large as possible for easy reading.
It is recommended not to justify texts.
We ensure that your technical documentation is always spot-on and compliant with the requirements established by the competent authority.
Given the confidential and technical nature of regulatory documentation, our translators and proofreaders are not only trained on the use of specific terminology but also in the procedures required to submit marketing authorizations. That’s how we guarantee that the final content is always clear and relevant to the process.
Specialized translators & reviewers
Technical terminology
Clear and accurate translations
State-of-the-art technology
Let’s talk about your next project!
Localization
Other services
MDR is the new set of regulations governing the production and distribution of medical products in Europe. In this article, we tell you all about this new regulation.
Translation
Interpreting
Localization
Other services
