Hello, I am looking to understand the need for a CE mark on a product that will be distributed to the US only but the manufacturer is in the EU. They will private label their product with the US branded distributor info but are keeping the CE mark ...
T here’s limited regulatory guidance on gene therapies for many drug manufacturer s and how i t can be a struggle to develop successful strategies for CMC. At this upcoming RAPS workshop , @Janmeet Anant will ...
The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions. For the MDR, these are harmonized standard entries No. 18 through 25 and they relate to medical gloves, biological ...
Hi William, Our findings will be published in Therapeutic Innovation & Regulatory Science . I'll follow up when this is published. Please stay posted! Thanks, Blake ------------------------------ Blake Schouest San Marcos CA United States -- ...
Hi Sushma, Is your product already placed on the market in Israel ? or do you plan to register a new product? The guidance for registration can be found in the Ministry of health website in the following link, but I doubt it will be useful for non-Israelis ...
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