Refine by
Emas Services In United Kingdom
4 services found
by:European Device Solutions Limited based inWhitley Bay, UNITED KINGDOM
We are a leading supplier of Software Quality Assurance and Regulatory Advice to industry and academia with many years’ experience in FDA, EMA, & MHRA regulated life sciences industries in the UK, Ireland, US, Far East and the EU. Our services include the following devices: Medical devices (and accessories), In-vitro diagnostic devices (and accessories), Wellness / ...
by:OracleBio based inGlasgow, UNITED KINGDOM
Studies conducted in accordance with this standard provides assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible (EMA Website). For quantitative image analysis data to be included in a data package submitted to regulatory authorities, it is essential that it is generated using a workflow that is in accordance ...
Manufactured by:Invicro, LLC based inNeedham, MASSACHUSETTS (USA)
A PSMA-PET scan is a powerful molecular imaging technique that can accurately localize prostate cancer and assess the level of a tumor’s PSMA expression. There are currently two USFDA and one EMA-approved PSMA-PET agents that are widely used in both clinic and trials. In early 2022, the USFDA approved the first targeted radioligand therapy, 177Lu-PSMA-61, for use in men ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
At Catalent, our methodologies work toward reducing the overall costs and time it takes to get your product to the clinic. With decades of experience in analytical development, we understand our clients’ needs, the current regulatory environment, and have a history of the development and qualification of analytical methods. We operate with a forward-looking methodology by deploying robust ...