Operating on a global scale, the pharmaceutical industry has to provide translated materials to various linguistic markets. Whether you are focusing on regulatory submissions, patient information leaflets, or packaging labels—if the information in them is not translated with absolute accuracy, irrevocable consequences can occur.
Translation is required at many stages in the course of bringing a drug to market, including clinical research, regulatory submissions, manufacturing, marketing and packaging. While the direct cost of translation is very small, translation can have a surprisingly large effect—for better and for worse—on several crucial factors. These factors include the total cost of the trials, the time to market, the possibility of lawsuits or rejection by regulators and even the safety and efficacy of the marketed product.
For instance, regulators sometimes reject applications or delay their approval if the required translations are inadequate. As a result, cost can increase dramatically, and market entry can be delayed by months if not years, with loss of competitiveness.
The typical documents we translate for our
Pharmaceutical Industry clients include:
Case Report Forms (CRF)
Drug Registration Documentation
Package Inserts and Labels
Manufacturing Process Description