{"id":278,"date":"2016-03-30T07:24:50","date_gmt":"2016-03-30T11:24:50","guid":{"rendered":"https:\/\/www.regulatoryaffairs.com\/?page_id=278"},"modified":"2019-05-10T11:13:56","modified_gmt":"2019-05-10T15:13:56","slug":"submission-competencies","status":"publish","type":"page","link":"https:\/\/www.regulatoryaffairs.com\/what-we-do\/submission-competencies\/","title":{"rendered":"Submission Competencies"},"content":{"rendered":"<p>Our electronic competencies have grown and we continue to expand our knowledge base in harmony with FDA&#8217;s new initiatives.\u00a0 We submit electronic INDs and DMFs.\u00a0 We use eSubmitter for Center for Veterinery Medicine.\u00a0 But more than the operational component, we have completed successful filings for drug-device combinations, excipient DMFs, device Master Files, and Index Listings via CVM&#8217;s Office of Minor Use Minor Species (MUMs).<\/p>\n<ul class=\"checkmarks\">\n<li>Managed ESG Client Accounts<\/li>\n<li>Secure Cloud File Exchange<\/li>\n<li>Secure Cloud Project and Task Manager<\/li>\n<li>Current XML eCTD Publisher<\/li>\n<li>Current XML eCTD Validator<\/li>\n<li>eSubmitter<\/li>\n<li>Document Management System (Cloud and Premises)<\/li>\n<li>Off-site Multiple Backup Systems (Cloud)<\/li>\n<li>Project Management Tools (Cloud)<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Our electronic competencies have grown and we continue to expand our knowledge base in harmony with FDA&#8217;s new initiatives.\u00a0 We submit electronic INDs and DMFs.\u00a0 We use eSubmitter for Center for Veterinery Medicine.\u00a0 But more than the operational component, we have completed successful filings for drug-device combinations, excipient DMFs, device Master Files, and Index Listings [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":26,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Submission Competencies - Clementi &amp; 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