{"id":1309,"date":"2026-03-24T09:58:17","date_gmt":"2026-03-24T08:58:17","guid":{"rendered":"https:\/\/www.op-pharma.it\/technical-documentation\/"},"modified":"2026-05-26T15:59:09","modified_gmt":"2026-05-26T14:59:09","slug":"technical-documentation","status":"publish","type":"page","link":"https:\/\/www.op-pharma.it\/en\/technical-documentation\/","title":{"rendered":"Technical Documentation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1309\" class=\"elementor elementor-1309 elementor-26\" 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data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42fa364 e-flex e-con-boxed e-con e-parent\" data-id=\"42fa364\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43c7563 elementor-widget elementor-widget-bdt-breadcrumbs\" data-id=\"43c7563\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"bdt-breadcrumbs.default\">\n\t\t\t\t\t<div class='bdt-ep-breadcrumbs-wrapper'><ul class=\"bdt-ep-breadcrumb breadcrumb-align-left  \"><li><a href=\"https:\/\/www.op-pharma.it\/en\/\">OP PHARMA<\/a><\/li>\n<li><span> Page<\/span><\/li>\n<\/ul><\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20cbe4b elementor-widget elementor-widget-heading\" data-id=\"20cbe4b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Technical Documentation<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-11d2091 e-flex e-con-boxed e-con e-parent\" data-id=\"11d2091\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7d43cd1 e-con-full e-flex e-con e-child\" data-id=\"7d43cd1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-947d9ea elementor-widget elementor-widget-heading\" data-id=\"947d9ea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Due Diligence Project and Solution, from digitalization to Base-Line e-CTD<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d8bb914 elementor-widget elementor-widget-text-editor\" data-id=\"d8bb914\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li>Due Diligence and eCTD Base Line Creation;<\/li><li>Digitization of paper technical dossiers;<\/li><li>CTD \/ NeeS \/ eCTD drafting from analytical and \/ or productive documentation;<\/li><li>Conversion from NtA to CTD\/NeeS\/eCTD;<\/li><li>Updating and management of electronic documentation (CTD\/NeeS\/eCTD);<\/li><li>Preparation, integration and sending of sections for New Applications, Responses, Variations and Renewals;<\/li><li><strong>eCTD Modules Submission EU\/CESP \u2013 GCC\/SFDA\/SDR \u2013 FDA\/ESG.<\/strong><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fc3b5b8 e-flex e-con-boxed e-con e-parent\" data-id=\"fc3b5b8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_top&quot;:&quot;opacity-tilt&quot;,&quot;shape_divider_bottom&quot;:&quot;opacity-tilt&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-shape elementor-shape-top\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 2600 131.1\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M0 0L2600 0 2600 69.1 0 0z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.5\" d=\"M0 0L2600 0 2600 69.1 0 69.1z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.25\" d=\"M2600 0L0 0 0 130.1 2600 69.1z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 2600 131.1\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M0 0L2600 0 2600 69.1 0 0z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.5\" d=\"M0 0L2600 0 2600 69.1 0 69.1z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.25\" d=\"M2600 0L0 0 0 130.1 2600 69.1z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a381727 elementor-widget elementor-widget-text-editor\" data-id=\"a381727\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>e-Dox<\/strong> is a web-based system for the secure management of sequences (before\/after the baseline) of <strong>eCTD<\/strong> dossiers in accordance with current<strong> ICH <\/strong>guidelines.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-11cf5af e-con-full e-flex e-con e-parent\" data-id=\"11cf5af\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-0af32a5 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"0af32a5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;shape_divider_top&quot;:&quot;opacity-tilt&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:1308,&quot;url&quot;:&quot;https:\\\/\\\/www.op-pharma.it\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/PAGINA-EDOX.jpg&quot;},{&quot;id&quot;:1307,&quot;url&quot;:&quot;https:\\\/\\\/www.op-pharma.it\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/eDox5.jpg&quot;}],&quot;background_slideshow_slide_duration&quot;:4000,&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500}\">\n\t\t\t\t<div class=\"elementor-shape elementor-shape-top\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 2600 131.1\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M0 0L2600 0 2600 69.1 0 0z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.5\" d=\"M0 0L2600 0 2600 69.1 0 69.1z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.25\" d=\"M2600 0L0 0 0 130.1 2600 69.1z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-509ee72 e-con-full e-flex e-con e-child\" data-id=\"509ee72\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-24ed91b elementor-widget elementor-widget-heading\" data-id=\"24ed91b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">e-Dox<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ccc3b8d elementor-widget elementor-widget-heading\" data-id=\"ccc3b8d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">eCTD Management, Submission and Sharing for secure management and sharing of eCTD sequences.\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f10083a elementor-widget elementor-widget-text-editor\" data-id=\"f10083a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Through e-Dox it is possible to <b>perform submissions<\/b> to any regulatory authority that accepts the eCTD format.<\/p><p>The approved documentation is always available for consultation and <b>download<\/b>: individual sections in <b>Word<\/b> format for preparing a new variation, <b>eCTD<\/b>, <b>consolidated dossier.<\/b><\/p><p>The updated sections within a sequence are visibly tracked in the interface and, once approved, become <b>unmodifiable by any user (structure\/content).<\/b><\/p><p>From the portal it is possible to share dossier sections, granting <b>third parties<\/b> (active substance\/product manufacturing sites, regulatory authorities, other MAHs) <b>scheduled and client-defined access<\/b> (including access limited to specific eCTD sections) for consultation purposes.<\/p><p><b>No installation is required,<\/b> only an Internet connection.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-095e0df e-grid e-con-full e-con e-child\" data-id=\"095e0df\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-efe3d3b elementor-flip-box--effect-slide elementor-flip-box--direction-right elementor-widget elementor-widget-flip-box\" data-id=\"efe3d3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper elementor-view-default\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-icon\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t\tSystem security\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tOP Pharma\u2019s IT system is protected by antivirus, firewall, and weekly data backups.\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-94c3e66 elementor-flip-box--effect-slide elementor-flip-box--direction-right elementor-widget elementor-widget-flip-box\" data-id=\"94c3e66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper elementor-view-default\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-icon\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t\tFilters\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tThe firewall filters system access: only the IPs of accredited clients can access the portal.\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b778fc4 elementor-flip-box--effect-slide elementor-flip-box--direction-right elementor-widget elementor-widget-flip-box\" data-id=\"b778fc4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper elementor-view-default\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-icon\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t\tBackup\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tData backups are performed weekly in duplicate, and a copy is provided directly to the client via FTP.\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>OP PHARMA Technical Documentation Due Diligence Project and Solution, from digitalization to Base-Line e-CTD Due Diligence and eCTD Base Line Creation; Digitization of paper technical dossiers; CTD \/ NeeS \/ eCTD drafting from analytical and \/ or productive documentation; Conversion from NtA to CTD\/NeeS\/eCTD; Updating and management of electronic documentation (CTD\/NeeS\/eCTD); Preparation, integration and sending [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-1309","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.op-pharma.it\/en\/wp-json\/wp\/v2\/pages\/1309","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.op-pharma.it\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.op-pharma.it\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.op-pharma.it\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.op-pharma.it\/en\/wp-json\/wp\/v2\/comments?post=1309"}],"version-history":[{"count":3,"href":"https:\/\/www.op-pharma.it\/en\/wp-json\/wp\/v2\/pages\/1309\/revisions"}],"predecessor-version":[{"id":1472,"href":"https:\/\/www.op-pharma.it\/en\/wp-json\/wp\/v2\/pages\/1309\/revisions\/1472"}],"wp:attachment":[{"href":"https:\/\/www.op-pharma.it\/en\/wp-json\/wp\/v2\/media?parent=1309"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}