{"id":3474,"date":"2016-12-26T09:16:10","date_gmt":"2016-12-26T17:16:10","guid":{"rendered":"\/?p=3474"},"modified":"2022-05-02T03:47:01","modified_gmt":"2022-05-02T08:47:01","slug":"2016-submit-psur-ectd-format","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/news\/announcement\/2016-submit-psur-ectd-format\/","title":{"rendered":"Submit your PSUR in eCTD format with eCTD247"},"content":{"rendered":"<p>Since June 2016, <a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Regulatory_and_procedural_guideline\/2016\/06\/WC500208531.pdf\"><span style=\"color: #f7913a;\">an EMA guideline<\/span><\/a> states that marketing authorisation holders must\u00a0submit E.U.\u00a0Periodic Safety Update Reports (PSUR):<\/p>\n<ul>\n<li>In eCTD or NeeS format<\/li>\n<li>To the central PSUR repository, using EMA&#8217;s\u00a0eSubmission Gateway \/ Web client<\/li>\n<\/ul>\n<p><strong>A simple and effective solution: <a href=\"http:\/\/www.ectd247.com\/\"><span style=\"color: #f7913a;\">eCTD247<\/span><\/a><\/strong><br \/>\n<a href=\"http:\/\/www.ectd247.com\/\"><span style=\"color: #f7913a;\">eCTD247<\/span><\/a> enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time.<br \/>\neCTD247 also:<\/p>\n<ul>\n<li>Is the only online eCTD solution<\/li>\n<li>Has a <a href=\"http:\/\/www.ectd247.com\/\"><span style=\"color: #f7913a;\">pricing based on the number of documents<\/span><\/a> in your submissions.<\/li>\n<li>Is very easy to use, with minimal training time to become efficient and start publishing and submitting your eCTD<\/li>\n<\/ul>\n<p>As a specialist of <a href=\"https:\/\/en.ennov.com\/regulatory-content-information-management\/dossier-submission-publishing\/\">eCTD software<\/a>, Ennov has devised the most practical and cost effective solution for submitting PSUR in eCTD or NeeS format.<br \/>\n<strong>All inclusive submission service<\/strong><br \/>\nIf you do not have the time to edit your eCTD PSUR by yourself, we can also propose you an all inclusive service for your PSUR submission.<br \/>\nPlease refer to the <a href=\"http:\/\/www.ectd247.com\/\"><span style=\"color: #f7913a;\">eCTD247.com web site<\/span><\/a> or <a href=\"http:\/\/www.ectd247.com\/contact\/\"><span style=\"color: #f7913a;\">Contact us<\/span><\/a> for more information. You will find a <a href=\"http:\/\/ectd247.com\/ectd-psur-submissions-faq\/\"><span style=\"color: #f7913a;\">convenient FAQ<\/span><\/a> that answers all your questions regarding PSUR eCTD submissions.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Since June 2016, an EMA guideline states that marketing authorisation holders must\u00a0submit E.U.\u00a0Periodic Safety Update Reports (PSUR): In eCTD or NeeS format To the central PSUR repository, using EMA&#8217;s\u00a0eSubmission Gateway \/ Web client A simple and effective solution: eCTD247 eCTD247 enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time. [&hellip;]<\/p>\n","protected":false},"author":232,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[174,37],"tags":[],"type_content":[],"job":[],"employees_type":[],"class_list":["post-3474","post","type-post","status-publish","format-standard","hentry","category-announcement","category-news","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.2.1 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Submit your PSUR in eCTD format with eCTD247<\/title>\n<meta name=\"description\" content=\"Marketing authorisation holders must\u00a0submit Periodic Safety Update Reports. 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