{"id":1329,"date":"2026-03-20T15:56:19","date_gmt":"2026-03-20T14:56:19","guid":{"rendered":"https:\/\/exalon.werbebaustelle.de\/ectd-services\/ectd-publishing\/"},"modified":"2026-04-24T11:49:33","modified_gmt":"2026-04-24T09:49:33","slug":"ectd-publishing","status":"publish","type":"page","link":"https:\/\/exalon.werbebaustelle.de\/de\/ectd-services\/ectd-publishing\/","title":{"rendered":"eCTD Erstellung"},"content":{"rendered":"<style>.kb-row-layout-id1329_a5cce4-e6 > .kt-row-column-wrap{align-content:start;}:where(.kb-row-layout-id1329_a5cce4-e6 > .kt-row-column-wrap) > .wp-block-kadence-column{justify-content:start;}.kb-row-layout-id1329_a5cce4-e6 > .kt-row-column-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:var(--global-kb-gap-md, 2rem);grid-template-columns:minmax(0, 1fr);}.kb-row-layout-id1329_a5cce4-e6 > .kt-row-layout-overlay{opacity:0.30;}@media all and (max-width: 1024px){.kb-row-layout-id1329_a5cce4-e6 > .kt-row-column-wrap{grid-template-columns:minmax(0, 1fr);}}@media all and (max-width: 767px){.kb-row-layout-id1329_a5cce4-e6 > .kt-row-column-wrap{grid-template-columns:minmax(0, 1fr);}}<\/style><div class=\"kb-row-layout-wrap kb-row-layout-id1329_a5cce4-e6 alignnone wp-block-kadence-rowlayout\"><div class=\"kt-row-column-wrap kt-has-1-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top\">\n<style>.kadence-column1329_3d0a80-7b > .kt-inside-inner-col,.kadence-column1329_3d0a80-7b > .kt-inside-inner-col:before{border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;}.kadence-column1329_3d0a80-7b > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column1329_3d0a80-7b > .kt-inside-inner-col{flex-direction:column;}.kadence-column1329_3d0a80-7b > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column1329_3d0a80-7b > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column1329_3d0a80-7b{position:relative;}@media all and (max-width: 1024px){.kadence-column1329_3d0a80-7b > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column1329_3d0a80-7b > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column1329_3d0a80-7b\" data-aos=\"fade-left\" data-aos-duration=\"1000\"><div class=\"kt-inside-inner-col\"><style>.wp-block-kadence-advancedheading.kt-adv-heading1329_78f318-77, .wp-block-kadence-advancedheading.kt-adv-heading1329_78f318-77[data-kb-block=\"kb-adv-heading1329_78f318-77\"]{line-height:1em;font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading1329_78f318-77, .wp-block-kadence-advancedheading.kt-adv-heading1329_78f318-77[data-kb-block=\"kb-adv-heading1329_78f318-77\"] .kb-adv-text-inner{background-image:linear-gradient(135deg,var(--global-palette3) 0%,var(--global-palette6) 100%);background-clip:text;-webkit-box-decoration-break:clone;box-decoration-break:clone;-webkit-background-clip:text;-webkit-text-fill-color:transparent;}.wp-block-kadence-advancedheading.kt-adv-heading1329_78f318-77 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading1329_78f318-77[data-kb-block=\"kb-adv-heading1329_78f318-77\"] mark.kt-highlight{font-style:normal;-webkit-text-fill-color:initial !important;-webkit-background-clip:initial !important;background-clip:initial !important;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading1329_78f318-77 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading1329_78f318-77[data-kb-block=\"kb-adv-heading1329_78f318-77\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style><h1 class=\"kt-adv-heading1329_78f318-77 wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading1329_78f318-77\"><span class=\"kb-adv-text-inner\">eCTD Erstellung<\/span><\/h1>\n\n\n<p>Die elektronische Einreichung von Zulassungsunterlagen f\u00fcr humane Arzneimittel im eCTD Format bildet den globalen Standard und wird in zunehmenden Ma\u00dfe von Zulassungsbeh\u00f6rden auch au\u00dferhalb der ICH Regionen empfohlen und teilweise auch verlangt. Wir bieten Ihnen:<\/p>\n\n\n<style>.wp-block-kadence-iconlist.kt-svg-icon-list-items1329_d60cdc-9e:not(.this-stops-third-party-issues){margin-top:0px;margin-bottom:0px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items1329_d60cdc-9e ul.kt-svg-icon-list:not(.this-prevents-issues):not(.this-stops-third-party-issues):not(.tijsloc){margin-top:0px;margin-right:0px;margin-bottom:var(--global-kb-spacing-sm, 1.5rem);margin-left:0px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items1329_d60cdc-9e ul.kt-svg-icon-list{grid-row-gap:5px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items1329_d60cdc-9e .kb-svg-icon-wrap{color:var(--global-palette1, #3182CE);}.wp-block-kadence-iconlist.kt-svg-icon-list-items1329_d60cdc-9e ul.kt-svg-icon-list .kt-svg-icon-list-item-wrap .kt-svg-icon-list-single{margin-right:10px;}.kt-svg-icon-list-items1329_d60cdc-9e ul.kt-svg-icon-list .kt-svg-icon-list-level-0 .kt-svg-icon-list-single svg{font-size:20px;}<\/style>\n<div class=\"wp-block-kadence-iconlist kt-svg-icon-list-items kt-svg-icon-list-items1329_d60cdc-9e kt-svg-icon-list-columns-1 alignnone kt-list-icon-aligntop\"><ul class=\"kt-svg-icon-list\"><style>.kt-svg-icon-list-item-1329_ea9089-4c .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_ea9089-4c\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>ERSTELLUNG UND EINREICHUNG<\/strong> von eCTDs (und NeeS) weltweit f\u00fcr alle Zulassungsverfahren und alle Arten von Arzneimittel<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1329_11e125-28 .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_11e125-28\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>PFLEGE<\/strong> des kompletten eCTD Lifecycles von der Zulassung bis zur Maintenance<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1329_963875-83 .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_963875-83\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>EINHALTUNG<\/strong> aller regionalen Spezialanforderungen wie z.B. die Erstellung von Study Tagging Files (STFs) und Produktinformation im SPL Format f\u00fcr US- Einreichungen<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1329_32d974-6b .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_32d974-6b\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>UPLOAD<\/strong> von eCTDs zur FDA, EMA, EU Beh\u00f6rden<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1329_1035d7-3d .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_1035d7-3d\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>FORMATIERUNG<\/strong> von eCTD-Dokumenten<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1329_cd3ab9-a8 .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_cd3ab9-a8\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>UNTERST\u00dcTZUNG<\/strong> bei \u201ePre-Submission Meetings\u201c<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1329_133884-47 .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_133884-47\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>GARANTIERTE EINHALTUNG<\/strong> aller aktuellen Beh\u00f6rdenanforderungen und Validierungskriterien zum eCTD<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1329_c0e67a-df .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_c0e67a-df\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>REALISIERUNG<\/strong> auch der herausfordernsten Einreichungstermine<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1329_684bdc-d31 .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1329_684bdc-d31\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\"><strong>VOR-ORT UNTERST\u00dcTZUNG<\/strong> bei der eCTD Erstellung, falls Ihre Zeit und\/oder Personal mal knapp sein sollten.<\/span><\/li>\n<\/ul><\/div>\n\n\n\n<p>\u00dcbrigens: Auf unserer\u00a0<a href=\"https:\/\/exalon.werbebaustelle.de\/about\/posts\/\" data-type=\"page\" data-id=\"39\">Blog Seite<\/a>\u00a0finden Sie die aktuellen Informationen von Beh\u00f6rden und relevanten Institutionen weltweit.<\/p>\n<\/div><\/div>\n\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>eCTD Erstellung Die elektronische Einreichung von Zulassungsunterlagen f\u00fcr humane Arzneimittel im eCTD Format bildet den globalen Standard und wird in zunehmenden Ma\u00dfe von Zulassungsbeh\u00f6rden auch au\u00dferhalb der ICH Regionen empfohlen und teilweise auch verlangt. Wir bieten Ihnen: \u00dcbrigens: Auf unserer\u00a0Blog Seite\u00a0finden Sie die aktuellen Informationen von Beh\u00f6rden und relevanten Institutionen weltweit.<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1324,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"class_list":["post-1329","page","type-page","status-publish","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":false,"author_info":{"display_name":"DC","author_link":"https:\/\/exalon.werbebaustelle.de\/de\/author\/admin-dc\/"},"comment_info":0,"_links":{"self":[{"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/pages\/1329","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/comments?post=1329"}],"version-history":[{"count":2,"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/pages\/1329\/revisions"}],"predecessor-version":[{"id":1333,"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/pages\/1329\/revisions\/1333"}],"up":[{"embeddable":true,"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/pages\/1324"}],"wp:attachment":[{"href":"https:\/\/exalon.werbebaustelle.de\/de\/wp-json\/wp\/v2\/media?parent=1329"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}