Multilingual Labeling for Clinical Studies & Post-Marketing Clinical Research
The clinical label development processes is increasingly complex with the continuous evolution of regulations and the need to meet shorter timelines.
Translations into the native language of potential users require comprehension of local regulations and a team that knows how to adhere to them properly. Our labeling activities include, but are not limited to, the disciplinary areas of clinical studies and post-market clinical research for which CQ fluency works either in direct partnership with the pharmaceutical, medical device and biotech industries, or via their Clinical Research Organizations (CROS).
CQ fluency does not simply “check the box.” We understand how important a label is for investigational medicinal products (IMPs) and we are passionate in getting it right as these labels are important in protecting your patients by providing identification, traceability, proper use instructions and more. We also understand how important it is to have proper documentation of the trial to substantiate the integrity of your study.
We are specialists of global regulatory reviews of packaging and labels for clinical and post-approval phases. Our expertise crosses multiple life-science verticals, including:
- Medical Devices
- Medical Technology
- Supplements & Nutraceuticals
Our Global Labeling Scope
Our work is international in nature – Europe, North America, Asia, Latin America, Middle East, Africa and more.
To complement our in-house expertise, we have a global network of global regulatory affairs specialists covering over 190 countries.
Our services include regulatory assessments of local label and packaging laws required for multinational clinical studies, creation and translation of content for label pack and user information into over 130 languages, creation of glossaries and summaries of local laws and guidance for future submissions, monitoring of international regulations and reporting with updates.
Contact us to learn more about how we can help you with your clinical labelling projects.