In a lot of countries, the documents need to submit not in English, but in their native languages. For example- in Russia and Russian speaking countries, some Asian countries like China, South Korea, Japan ect, American countries like Brazil, Mexico ect and most European countries. Our translation team can translate the full dossier, and make the dossier as per local requirement.
The Health Authorities requires to translate different documents such as informed consent, patient information leaflet, instructions for use, safety information and more into the native languages. Mistakes or missing text in a translation may be costly, e.g. in a case in which there is a need for recall and may even lead to harm to the patients, e.g. due to incorrect translation of the instructions for use of the medicine or medical device.
Our regulatory affairs team has the expertise, long-term experience preparing and compiling the registration dossiers for all categories of medical devices and IVDs in line with the latest regulatory requirements in multiple countries before submitting them to the appropriate health authorities.
Barrco Regulatory Solutions offers you, whether a business customer or private customer unwilling to compromise on the quality of translation, medical and pharmaceutical translation services of the highest level whilst ensuring the accuracy of the medical/pharmaceutical terms, clear wording throughout the translated text whilst working within the schedule agreed upon.