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The EU Medical Device Regulation, in force since 2017, reaches its first milestone on May 26, 2021 (as it was postponed due to the Covid-19 pandemic), when manufacturers of medical devices will have to comply with the new legislation. What are the main changes that the new MDR will introduce and what will manufacturers need […]
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The clinical trial setting is changing like never before with a flood of new technologies, regulatory flux, Brexit, the Clinical Trial Regulation coming into effect in 2019 and the constant flow of new innovations. As many of the processes involved in clinical trials are now outsourced, drug trial sponsors and CROs, like those attending the […]
Keep readingWhat exactly is BioWales and who will be there? The BioWales conference brings together stakeholders from business, academia and healthcare, who come to share their front-line research, technology and products and form strategic partnerships with others in the field. The conference is planned with interactive workshops, seminars, networking opportunities, dedicated partnering sessions and presentations from […]
Keep readingMarketing any medical device on a global scale involves a product strategy that requires language translation and localization. Many countries impose directives that require companies to translate product information into the language of the local user. The question for medical device manufacturers is not whether or not they need to translate for their target markets, […]
Keep readingThese days, hundreds of clinical trials enable pharmaceutical and medical companies all over the world to advance pharmacological knowledge and enhance patient care. Accurate, professional translations of Clinical Trial Protocols (CTPs) are a core element to conducting effective, safe international multi-centre trials: they facilitate the enrollment, treatment and monitoring of a diverse cross-section of participants […]
Keep readingTranslating medicine packaging and labeling information accurately and appropriately for international markets is a challenge that cannot be faced lightly. Imagine a regulatory affairs manager or lead buyer in purchasing staring down at their desk one rainy afternoon, somewhat concerned about an email from senior management that simply states: find a good medical translation supplier […]
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