More and more clinical trials are conducted in a multi-national environment every day. FDA (Food and Drug Administration) data confirm this fact. According to them, the majority of medications present on the US market are imported and produced outside the USA. For example, the number of clinical trials conducted in the USA has decreased from 80% to 24% according to the FDA study on approved oncology medications. On the other hand, the number of approved medications developed as a result of clinical trials conducted internationally has risen from 50% during 1998-1999 to75% during 2000-2002.
Translation services are necessary in many phases of the marketing procedure of a medication, such as: clinical trials, regulatory procedures, production, marketing and packaging etc. While translation costs are relatively low, opting not to translate can have a much bigger effect on a large number of factors related to the production of medications, starting from pharmaceutical study costs, compliance with country-specific procedural characteristics, to new medications’ safety.
Imagine regulatory authorities of one country rejecting a new medication because the translation of its documentation is inappropriate. As a result, production costs would rise dramatically and placing the product on the market would be postponed for months or even years, which would reduce the product’s competitive value.
Pharmaceutical translations require accuracy and technical expertise of all the translators working on the project. This standpoint entails a high command of translation skills, but also understanding of the strict regulatory laws on developing a new medication.
The company „Mediante“ works with the translators who have successfully been translating for the leading pharmaceutical companies in Serbia for many years now, and who make their best efforts to produce a clear and accurate translation of high-value information for all our clients, day after day.