{"id":19,"date":"2013-02-11T09:47:48","date_gmt":"2013-02-11T13:47:48","guid":{"rendered":"https:\/\/www.regulatoryaffairs.com\/?page_id=19"},"modified":"2019-10-17T10:00:48","modified_gmt":"2019-10-17T14:00:48","slug":"rc-regulatory-competences","status":"publish","type":"page","link":"https:\/\/www.regulatoryaffairs.com\/what-we-do\/rc-regulatory-competences\/","title":{"rendered":"Regulatory Competencies"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:30px;padding-bottom:0px;padding-left:30px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-1\"><p>Our regulatory competencies are based on the types of submissions we make and how often we make. \u00a0In the past 12 months we have filed over a 100 submissions to CDER, CBER and CVM.<\/p>\n<ul class=\"checkmarks\">\n<li>Filing of numerous INDs for CDER, CBER and INADs for CVM<\/li>\n<li>Request numerous Type B and C Meetings within each Center<\/li>\n<li>Successful Orphan Drug Designation<\/li>\n<li>IND Life Cycle Management, Annual Reports, Protocol Amendments<\/li>\n<li>File eCTD Drug Master Files (Type II and IV)<\/li>\n<li>Navigate Expanded Use Initiatives<\/li>\n<li>Navigate and Resolve IND Hold Issues<\/li>\n<li>Develop Phase I Safety Assessment Programs for SAD and MAD Studies<\/li>\n<li>Publication Management (clintrials.gov for US clients only)<\/li>\n<li>IND Waivers; Pediatric Study Waivers; User Fee Waivers<\/li>\n<li>IDE and 510k for Devices<\/li>\n<\/ul>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":26,"menu_order":0,"comment_status":"open","ping_status":"open","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>Regulatory Competencies - Clementi &amp; Associates<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.regulatoryaffairs.com\/what-we-do\/rc-regulatory-competences\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Competencies - Clementi &amp; 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