medDOC® supplies major pharmaceutical companies with quality-assured translations in all languages.
Licensed and registered pharmaceutical products are subject to extremely strict national regulations and restrictions on their use, which have to be detailed on the patient information leaflet, for example. These can vary from country to country, and play an important role in terms of country-specific localisation when translating documentation.
Translations that form part of the licensing (marketing authorisation) procedure for pharmaceutical products are very large documents (the prescribed Common Technical Document (CTD) may comprise several thousand pages), and the success of the licensing application can depend on accurate translation of, for example, product information, details of the pharmacovigilance system, chemical, pharmaceutical and biological data of the drug, study reports and all clinical and non-clinical trials.
In this lengthy procedure, medDOC® provides language support to our very demanding clients in the pharmaceuticals sector. In this role, our expert knowledge and great attention to detail are vital. Quality-assured translations are delivered on time, with particular priority given to the translation of clinical studies, in line with their importance.
The service provided by medDOC® also includes translation of all the documents required by the European Medicines Agency (EMA) and/or the Food and Drug Administration (FDA) in America. This, of course, means meeting strict deadlines.
In addition, we support our pharmaceutical clients in all other areas where translations into various languages are required, e.g. marketing and advertising, training materials, quality manuals, pharmacovigilance/risk management documentation and product information.
Summary of product characteristics (SmPC) and package information leaflet (PIL) are translated in accordance with the corresponding QRD templates.
Our principal objective is to assist our clients in all aspects of translation by providing expert advice and an optimised workflow in order to shorten production times, reduce costs and guarantee the requisite high quality.