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Regulatory Affairs

We provide specialized translation and localization services to smooth the process of submitting marketing authorizations with the competent health authority.

Regulatory affairs and
market access solutions

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.

Mandatory documentation

Each agency has its requirements, and they vary by market and product. The European Medicines Agency (EMA), for instance, requires that the summaries of the technical sheets, prospects, and labeling, among others, be provided in the languages of all the member states where the product is marketed.

Some of the documents we translate:

Language requirements
for Market Authorizations

Beyond language

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.


It is recommended to use short and clear sentences.

We ensure that your technical documentation is always spot-on and compliant with the requirements established by the competent authority.

Our localization solutions for
companies in the pharmaceutical sector

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!

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.