{"id":26,"date":"2018-03-09T15:21:45","date_gmt":"2018-03-09T14:21:45","guid":{"rendered":"http:\/\/exalon.webseiten.cc\/?page_id=26"},"modified":"2023-11-03T16:28:08","modified_gmt":"2023-11-03T15:28:08","slug":"home","status":"publish","type":"page","link":"https:\/\/exalon.com\/de\/","title":{"rendered":"Startseite"},"content":{"rendered":"<div class=\"row\"> <div class=\"col-md-8  \">\n<h2>Willkommen bei Exalon<\/h2>\n<h4>Ihr Partner f\u00fcr eCTDs und NeeS mit h\u00f6chsten Qualit\u00e4tsanspr\u00fcchen<\/h4>\n<p>Wir sind spezialisiert auf die Erstellung und\u00a0Einreichung von elektronischen Zulassungsdossiers wie eCTD oder NeeS f\u00fcr alle Arten von Arzneimitteln und Zulassungsverfahren weltweit.<\/p>\n<p>Von der Formatierung einzelner eCTD Zulassungsdokumente bis hin zur kompletten Abwicklung des gesamten eCTD Erstellungs &#8211; und Einreichungsprozesses inklusive Pflege des eCTD Lifecycles bieten wir Ihnen eine breite Palette unserer Dienstleistungen an. Profitieren Sie dabei von unserer langj\u00e4hrigen eCTD-Erfahrung aus der globalen pharmazeutischen Industrie!<\/p>\n<p>Nat\u00fcrlich begleiten und unterst\u00fctzen wir auch Firmen beratend bei der Einf\u00fchrung entsprechender eCTD-Systeme und eCTD-Prozesse.\u00a0<\/p>\n<p>Sie wollen<\/p>\n<ul>\n<li>Sich ganz auf die Inhalte Ihrer Zulassungsdossier konzentrieren statt sich um die\u00a0technischen und formalen Anforderungen eines eCTDs zu k\u00fcmmern?<\/li>\n<li>Die betr\u00e4chtlichen, zum Teil versteckten Anfangsinvestitionen und hohen laufenden Kosten\u00a0vermeiden, die mit einer eCTD in-house L\u00f6sung verbunden sind?<\/li>\n<li>Unabh\u00e4ngkeit von Software-L\u00f6sungen und Technologien und keine st\u00e4ndigen Updates?<\/li>\n<li>Und dabei einen zuverl\u00e4ssigen Partner mit langj\u00e4hriger praktischer eCTD-Erfahrung f\u00fcr alle Arten von Arzneimittelzulassungen weltweit?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h4>eCTD Implementierung<\/h4>\n<div class=\"map_wrapper\" id=\"map_wrapper_705\">\n<div class=\"map_box\" style=\"max-width:850px\">\n<div class=\"map_aspect_ratio\" style=\"padding-top:56%\" data-padding-top=\"56%\" data-padding-top-mobile=\"0%\">\n<div class=\"map_container\">\n<div class=\"map_render map_loading\" id=\"map_705\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n\n<div class=\"panel-group\" id=\"accordionname5\"><div class=\"panel panel-default panel-even\"><div class=\"panel-heading\"><a class=\"accordion-toggle collapsed\" data-toggle=\"collapse\" data-parent=\"#accordionname5\" href=\"#collapse50\"><h5><i class=\"icon-minus primary-color\"><\/i><i class=\"icon-plus\"><\/i>Listenansicht<\/h5><\/a><\/div><div id=\"collapse50\" class=\"panel-collapse collapse \"><div class=\"panel-body postclass\">\n<p>AE \u2013 United Arab Emirates \u2013 GCC<br \/>\nAM \u2013 Armenia \u2013 EAEU &#8222;eCTD&#8220;<br \/>\nAT \u2013 Austria<br \/>\nAU \u2013 Australia<br \/>\nBE \u2013 Belgium<br \/>\nBG \u2013 Bulgaria<br \/>\nBH \u2013 Bahrain \u2013 GCC<br \/>\nBR \u2013 Brazil \u2013 planned<br \/>\nBY \u2013 Belarus \u2013 EAEU &#8222;eCTD&#8220;<br \/>\nCA \u2013 Canada<br \/>\nCH \u2013 Switzerland<br \/>\nCN \u2013 China<br \/>\nCY \u2013 Cyprus<br \/>\nCZ \u2013 Czechia<br \/>\nDE \u2013 Germany<br \/>\nDK \u2013 Denmark<br \/>\nEE \u2013 Estonia<br \/>\nEG \u2013 Egypt \u2013 planned<br \/>\nES \u2013 Spain<br \/>\nFI \u2013 Finland<br \/>\nFR \u2013 France<br \/>\nGB \u2013 United Kingdom<br \/>\nGR \u2013 Greece<br \/>\nHR \u2013 Croatia<br \/>\nHU \u2013 Hungary<br \/>\nIE \u2013 Ireland<br \/>\nIS \u2013 Iceland<br \/>\nIT \u2013 Italy<br \/>\nJO \u2013 Jordan<br \/>\nJP \u2013 Japan<br \/>\nKE \u2013 Kenya \u2013 planned<br \/>\nKG \u2013 Kyrgyzstan \u2013 EAEU &#8222;eCTD&#8220;<br \/>\nKR \u2013 South Korea<br \/>\nKW \u2013 Kuwait \u2013 GCC<br \/>\nKZ \u2013 Kazakhstan \u2013 EAEU &#8222;eCTD&#8220;<br \/>\nLI \u2013 Liechtenstein<br \/>\nLT \u2013 Lithuania<br \/>\nLU \u2013 Luxembourg<br \/>\nLV \u2013 Latvia<br \/>\nMT \u2013 Malta<br \/>\nNL \u2013 Netherlands<br \/>\nNO \u2013 Norway<br \/>\nOM \u2013 Oman \u2013 GCC<br \/>\nPL \u2013 Poland<br \/>\nPT \u2013 Portugal<br \/>\nQA \u2013 Qatar \u2013 GCC<br \/>\nRO \u2013 Romania<br \/>\nRS \u2013 Serbia \u2013 planned<br \/>\nRU \u2013 Russia \u2013 EAEU &#8222;eCTD&#8220; (technically different to ICH eCTD)<br \/>\nSA \u2013 Saudi Arabia \u2013 GCC<br \/>\nSE \u2013 Serbia<br \/>\nSG \u2013 Singapore \u2013 planned<br \/>\nSI \u2013 Slovenia<br \/>\nSK \u2013 Slovakia<br \/>\nTH \u2013 Thailand<br \/>\nTW \u2013 Taiwan<br \/>\nUS \u2013 United States<br \/>\nZA \u2013 South Africa<\/p>\n<\/div><\/div><\/div><\/div>\n\n<p>&nbsp;<\/p>\n<\/div><div class=\"col-md-4  \">\n<h4>Unser X Feed<\/h4>\n\n<!-- Custom Twitter Feeds by Smash Balloon -->\n<div id=\"ctf\" role=\"region\" aria-label=\"Twitter Feed\" class=\" ctf ctf-type-usertimeline ctf-rebranded ctf-feed-1  ctf-styles ctf-list ctf-regular-style\"   data-ctfshortcode=\"{&quot;feed&quot;:&quot;1&quot;}\"   data-ctfdisablelinks=\"false\" data-ctflinktextcolor=\"#\" data-header-size=\"small\" data-feedid=\"1\" data-postid=\"26\"  data-feed=\"1\" data-ctf-flags=\"gdpr\" data-ctfneeded=\"-77\">\n        <div class=\"ctf-tweets\" role=\"list\">\n   \t\t\n<div role=\"listitem\"  class=\"ctf-item ctf-author-ectdexperts ctf-new ctf-hide-avatar\"  id=\"2112919745704128797\" >\n\n\t\n\t<div class=\"ctf-author-box\">\n\t\t<div class=\"ctf-author-box-link\">\n\t        \t\t\t\t\n\t\t\t\t\t\t\t\t\t<h3 class=\"ctf-author-name-heading\" style=\"display:inline;margin:0;padding:0;font:inherit;color:inherit;\"><a href=\"https:\/\/twitter.com\/ectdexperts\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"ctf-author-name\" >exalon<\/a><\/h3>\n\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/twitter.com\/ectdexperts\" class=\"ctf-author-screenname\" target=\"_blank\" rel=\"noopener noreferrer\" >@ectdexperts<\/a>\n\t\t\t\t\t<span class=\"ctf-screename-sep\">&middot;<\/span>\n\t\t\t\t\t        \n\t\t\t\t\t\t\t<div class=\"ctf-tweet-meta\" >\n\t\t\t\t\t<a href=\"https:\/\/twitter.com\/ectdexperts\/status\/2112919745704128797\" class=\"ctf-tweet-date\" target=\"_blank\" rel=\"noopener noreferrer\" >21 Okt.<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t    \n\t<\/div>\n\t<div class=\"ctf-tweet-content\">\n\t\t                <p class=\"ctf-tweet-text\">\n                                        A short reminder from EU EMA regarding the proper naming of electronic application forms (eAF) for centrally authorized products #eCTD #EMA https:\/\/esubmission.ema.europa.eu\/                                                        <\/p>\n            \t<\/div>\n\n\t\t\n<\/div>\n<div role=\"listitem\"  class=\"ctf-item ctf-author-ectdexperts ctf-new ctf-hide-avatar\"  id=\"2090783741601857594\" >\n\n\t\n\t<div class=\"ctf-author-box\">\n\t\t<div class=\"ctf-author-box-link\">\n\t        \t\t\t\t\n\t\t\t\t\t\t\t\t\t<h3 class=\"ctf-author-name-heading\" style=\"display:inline;margin:0;padding:0;font:inherit;color:inherit;\"><a href=\"https:\/\/twitter.com\/ectdexperts\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"ctf-author-name\" >exalon<\/a><\/h3>\n\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/twitter.com\/ectdexperts\" class=\"ctf-author-screenname\" target=\"_blank\" rel=\"noopener noreferrer\" >@ectdexperts<\/a>\n\t\t\t\t\t<span class=\"ctf-screename-sep\">&middot;<\/span>\n\t\t\t\t\t        \n\t\t\t\t\t\t\t<div class=\"ctf-tweet-meta\" >\n\t\t\t\t\t<a href=\"https:\/\/twitter.com\/ectdexperts\/status\/2090783741601857594\" class=\"ctf-tweet-date\" target=\"_blank\" rel=\"noopener noreferrer\" >21 Aug.<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t    \n\t<\/div>\n\t<div class=\"ctf-tweet-content\">\n\t\t                <p class=\"ctf-tweet-text\">\n                                        For EU Type IA\/Type IAin Variations, a cover letter is no longer required. (Source: EMA, CMDh). The requirement to include a Sequence Tracking Table remains. #RegulatoryAffairs #eCTD                                                        <\/p>\n            \t<\/div>\n\n\t\t\n<\/div>\n<div role=\"listitem\"  class=\"ctf-item ctf-author-ectdexperts ctf-new ctf-hide-avatar\"  id=\"2089263822691254607\" >\n\n\t\n\t<div class=\"ctf-author-box\">\n\t\t<div class=\"ctf-author-box-link\">\n\t        \t\t\t\t\n\t\t\t\t\t\t\t\t\t<h3 class=\"ctf-author-name-heading\" style=\"display:inline;margin:0;padding:0;font:inherit;color:inherit;\"><a href=\"https:\/\/twitter.com\/ectdexperts\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"ctf-author-name\" >exalon<\/a><\/h3>\n\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/twitter.com\/ectdexperts\" class=\"ctf-author-screenname\" target=\"_blank\" rel=\"noopener noreferrer\" >@ectdexperts<\/a>\n\t\t\t\t\t<span class=\"ctf-screename-sep\">&middot;<\/span>\n\t\t\t\t\t        \n\t\t\t\t\t\t\t<div class=\"ctf-tweet-meta\" >\n\t\t\t\t\t<a href=\"https:\/\/twitter.com\/ectdexperts\/status\/2089263822691254607\" class=\"ctf-tweet-date\" target=\"_blank\" rel=\"noopener noreferrer\" >17 Aug.<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t    \n\t<\/div>\n\t<div class=\"ctf-tweet-content\">\n\t\t                <p class=\"ctf-tweet-text\">\n                                        September 1st is approaching fast - please be reminded of the mandatory use of the PLM web-based eAFs for EU Centralized Procedure submissions! https:\/\/esubmission.ema.europa.eu\/cessp\/cessp.htm                                                        <\/p>\n            \t<\/div>\n\n\t\t\n<\/div>\n<div role=\"listitem\"  class=\"ctf-item ctf-author-ectdexperts ctf-new ctf-hide-avatar\"  id=\"2088267351758094418\" >\n\n\t\n\t<div class=\"ctf-author-box\">\n\t\t<div class=\"ctf-author-box-link\">\n\t        \t\t\t\t\n\t\t\t\t\t\t\t\t\t<h3 class=\"ctf-author-name-heading\" style=\"display:inline;margin:0;padding:0;font:inherit;color:inherit;\"><a href=\"https:\/\/twitter.com\/ectdexperts\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"ctf-author-name\" >exalon<\/a><\/h3>\n\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/twitter.com\/ectdexperts\" class=\"ctf-author-screenname\" target=\"_blank\" rel=\"noopener noreferrer\" >@ectdexperts<\/a>\n\t\t\t\t\t<span class=\"ctf-screename-sep\">&middot;<\/span>\n\t\t\t\t\t        \n\t\t\t\t\t\t\t<div class=\"ctf-tweet-meta\" >\n\t\t\t\t\t<a href=\"https:\/\/twitter.com\/ectdexperts\/status\/2088267351758094418\" class=\"ctf-tweet-date\" target=\"_blank\" rel=\"noopener noreferrer\" >14 Aug.<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t    \n\t<\/div>\n\t<div class=\"ctf-tweet-content\">\n\t\t                <p class=\"ctf-tweet-text\">\n                                        FDA issues Draft Guidance on Container Closure Systems for Human Drugs and Biological Products                                                         <\/p>\n            \t<\/div>\n\n\t\t\n<\/div>    <\/div>\n    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src=\"https:\/\/exalon.com\/wp-content\/plugins\/custom-twitter-feeds\/js\/ctf-scripts.min.js?ver=2.10.0\"><\/script>\n<\/div>\n\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-26","page","type-page","status-publish","hentry"],"translation":{"provider":"WPGlobus","version":"3.0.0","language":"de","enabled_languages":["en","de"],"languages":{"en":{"title":true,"content":true,"excerpt":false},"de":{"title":true,"content":true,"excerpt":false}}},"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.2.1 - aioseo.com -->\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<meta name=\"google-site-verification\" content=\"boCWYe21NiraSRAxpceSFH-tJOXQv9ydNotLBHP-S6o\" \/>\n\t<link rel=\"canonical\" href=\"https:\/\/exalon.com\/de\/\" \/>\n\t<meta name=\"generator\" 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