Translation is the key to a better life for pharma consumers in overseas markets, and the full measure of return for the pharmaceutical companies that develop and market them.
For over two decades, Responsive Translation has been helping clients like Merck, Pfizer, Bristol-Myers Squibb, Johnson & Johnson and Sanyo Pharma expand their reach to multiple markets. We take extreme care that our translation and review services are clinically valid and regulatory compliant using rigorous processes that ensure the greatest chances of regulatory and market success.
Electronic Common Technical Documents
While companies must still apply for marketing authorization with the regulatory bodies in each geographical territory, the process for reaching major markets has become easier in recent years. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), representing the United States, the European Union and Japan, has established a number of standards and brought them into common use, such as the eCTD, or Electronic Common Technical Document.
When seeking regulatory approval for a pharmaceutical drug to be marketed and sold in a particular geographical territory, eCTD is the standard format for this type of electronically submitted application. The content is organized into five modules, which are presented using xml files in a particular folder structure.
eCTDs are used in the United States, the European Union and Japan for marketing authorization applications submitted to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA). In addition, a number of countries outside the ICH also favor or accept eCTD submissions. Australia is only one example.
The Secret to International Expansion
Responsive Translation knows the high stakes involved in drug development and the demands of fast and accurate processing of eCTDs. For decades, we’ve helped the world’s top companies bring pharmaceutical drugs to new markets through accurate, clinically-valid translation designed to meet regulatory demands. The secret is in our approach to people and processes.
We start with highly-qualified teams of translators, reviewers and subject matter experts, as well as ISO-certified processes to drive continuous improvement. While all of our linguists are native speakers of the target language, are certified by the American Translators Association or equivalent, and regularly evaluated for quality, those who work with our drug clients are specifically chosen for their relevant experience and pharmaceutical specialization.
Isn’t it time to expand? Responsive Translation is a strategic partner that designs custom workflows and employs advanced terminology management to always keep your project on time, on target and within your budget without sacrificing quality or the end result.
Our meticulous review and quality assurance processes will guarantee that your eCTD translation is as perfect as can be and will meet prevailing clinical and regulatory standards.
If you would like to discuss your requirements for eCTD translation, or to receive more information on Responsive Translation’s range of clinical translation and review services, please contact us at +1-212-355-4455 or email@example.com.