Patient records for use in obtaining a second opinion abroad. Marketing authorizations. Package inserts. Medical equipment. Trial protocols. SOPs. In-vitro diagnostic equipment. Danish Medicines Agency, EMA and FDA. The biotech and pharmaceutical industry.
These are fields where many translators fear to tread. Medical translation is not part of the curriculum on the five-year education to become a translatør, so it’s a skill-set that has to be built, and we’ve been doing that for many years now. It all started with translating trial protocols for treating HIV patients, which we translated for ethics councils in collaboration with the doctors. That was back when HIV was tantamount to a death sentence. At the same time, we translated pacemaker manuals and embarked on the field of medical equipment. Since then we have honed our skills, and over the years we have translated for both the Danish and the European medicines agencies.
We translate SPCs and package inserts (PILs) according to the latest QRD templates from the EMA. We are also frequently involved in the communications between manufacturer and drug agencies when drugs have to be approved or the marketing authorization extended.
We also translate SOPs, for use for non-Danish-speaking staff as well as due diligence purposes etc. We are on top of the GDP and GMP terminology for the different languages. Medical products are a highly regulated area all round, where you need to know when and where to search for terminology from legislation, templates and EU directives.
If you contact us as a private individual and have patient records you need in order to get a second opinion or treatment abroad, we always recommend going through the records with your GP to identify those passages that are relevant to your translation needs. Not only will it work out cheaper for you, but we can have the translation ready that much sooner when there is less to translate. Unfortunately, time is often of the essence in such critical cases.