Regulatory Affairs Expertise

Our Methodology

We have successfully guided many international pharmaceutical companies through the regulatory requirements associated with translating pharmaceutical product information for regulatory submission and consumer use. We have also designed a number of internal standard operating procedures to dovetail with the European, Asian and U.S. regulatory bodies’ requirements for document types containing this content. At a minimum, all translations containing pharmaceutical product information go through a series of highly defined steps including translation conducted by two highly qualified linguists, multilingual multimedia production, an additional quality control edit, final pre-production review, in-country review and certification.

We also adhere to the translation methods required by global regulatory authorities. For example, we have a significant amount of experience managing the translation of drug labels and SmPCs. This process begins with our intimate familiarity with the EMA’s strict requirements, its Quality Review of Documents (QRD) group and each of the 23 Member State representatives responsible for ensuring local regulatory standards are met for each language.