{"id":11,"date":"2018-03-09T11:34:40","date_gmt":"2018-03-09T10:34:40","guid":{"rendered":"http:\/\/exalon.webseiten.cc\/glossary\/"},"modified":"2019-02-19T16:25:37","modified_gmt":"2019-02-19T15:25:37","slug":"master-files-cep","status":"publish","type":"page","link":"https:\/\/exalon.com\/de\/master-files-cep\/","title":{"rendered":"Master Files (ASMF, DMF, PMF), CEP"},"content":{"rendered":"<p>Exalon supports manufacturers (of drug substances, packaging materials, excipients etc.) in the <a href=\"https:\/\/exalon.com\/ectd\/ectd-publishing\/\">eCTD publishing<\/a> and submission of their dossiers:<\/p>\n<ul>\n<li><strong>ASMF<\/strong> (Active Substance Master Files)<\/li>\n<li><strong>DMF<\/strong> (Drug Master Files)<\/li>\n<li><strong>PMF<\/strong>\u00a0(Plasma Master Files)<\/li>\n<li><strong>CEP<\/strong> (Certificates of Suitability)<\/li>\n<\/ul>\n<p>Exalon offers an assessment of your documentation and recommendations on aspects such as <a href=\"https:\/\/exalon.com\/ectd\/ectd-readiness\/\">eCTD readiness<\/a>, approach for baselines submissions or multi-regional submissions (EU). Among others Exalon has a broad experience with <strong>DMFs for Packaging Materials<\/strong> (e.g. US Type III DMF, CA Type II DMF) \u2013 we provide advice on eCTD structure for multi-item packaging materials (based on authority recommendations and best-practice) and support adaptation of source documents.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Exalon supports manufacturers (of drug substances, packaging materials, excipients etc.) in the eCTD publishing and submission of their dossiers: ASMF (Active Substance Master Files) DMF (Drug Master Files) PMF\u00a0(Plasma Master Files) CEP (Certificates of Suitability) Exalon offers an assessment of &hellip; <a class=\"kt-excerpt-readmore\" href=\"https:\/\/exalon.com\/de\/master-files-cep\/\" aria-label=\"Master Files (ASMF, DMF, PMF), CEP\">Weiterlesen<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":10,"comment_status":"closed","ping_status":"closed","template":"page-feature.php","meta":{"footnotes":""},"class_list":["post-11","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":false,"content":false,"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\/master-files-cep\/\" \/>\n\t<meta name=\"generator\" content=\"All in One SEO (AIOSEO) 5.0.2.1\" \/>\n\t\t<meta property=\"og:locale\" content=\"de_DE\" \/>\n\t\t<meta property=\"og:site_name\" content=\"Exalon | eCTD-Experts\" \/>\n\t\t<meta property=\"og:type\" content=\"article\" \/>\n\t\t<meta property=\"og:title\" content=\"Master Files (ASMF, DMF, PMF), CEP | Exalon\" \/>\n\t\t<meta property=\"og:url\" content=\"https:\/\/exalon.com\/de\/master-files-cep\/\" \/>\n\t\t<meta property=\"article:published_time\" content=\"2018-03-09T10:34:40+00:00\" \/>\n\t\t<meta property=\"article:modified_time\" content=\"2019-02-19T15:25:37+00:00\" \/>\n\t\t<meta name=\"twitter:card\" content=\"summary\" \/>\n\t\t<meta name=\"twitter:title\" content=\"Master Files (ASMF, DMF, PMF), CEP | Exalon\" \/>\n\t\t<script type=\"application\/ld+json\" class=\"aioseo-schema\">\n\t\t\t{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/master-files-cep\\\/#breadcrumblist\",\"itemListElement\":[{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/#listItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/exalon.com\\\/de\\\/\",\"nextItem\":{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/master-files-cep\\\/#listItem\",\"name\":\"Master Files (ASMF, DMF, PMF), CEP\"}},{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/master-files-cep\\\/#listItem\",\"position\":2,\"name\":\"Master Files (ASMF, DMF, PMF), CEP\",\"previousItem\":{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/#listItem\",\"name\":\"Home\"}}]},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/#organization\",\"name\":\"Exalon \\u2013 eCTD-Experts\",\"description\":\"eCTD-Experts\",\"url\":\"https:\\\/\\\/exalon.com\\\/de\\\/\",\"telephone\":\"+4977329391650\",\"logo\":{\"@type\":\"ImageObject\",\"url\":\"https:\\\/\\\/exalon.com\\\/wp-content\\\/uploads\\\/Logo_Exalon_slogan_rgb.png\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/master-files-cep\\\/#organizationLogo\",\"width\":853,\"height\":340},\"image\":{\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/master-files-cep\\\/#organizationLogo\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/master-files-cep\\\/#webpage\",\"url\":\"https:\\\/\\\/exalon.com\\\/de\\\/master-files-cep\\\/\",\"name\":\"Master Files (ASMF, DMF, PMF), CEP | Exalon\",\"inLanguage\":\"de-DE\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/#website\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/master-files-cep\\\/#breadcrumblist\"},\"datePublished\":\"2018-03-09T11:34:40+01:00\",\"dateModified\":\"2019-02-19T16:25:37+01:00\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/#website\",\"url\":\"https:\\\/\\\/exalon.com\\\/de\\\/\",\"name\":\"Exalon\",\"description\":\"eCTD-Experts\",\"inLanguage\":\"de-DE\",\"publisher\":{\"@id\":\"https:\\\/\\\/exalon.com\\\/de\\\/#organization\"}}]}\n\t\t<\/script>\n\t\t<!-- All in One SEO -->\n\n","aioseo_head_json":{"title":"Master Files (ASMF, DMF, PMF), CEP | Exalon","description":"","canonical_url":"https:\/\/exalon.com\/de\/master-files-cep\/","robots":"max-image-preview:large","keywords":"","webmasterTools":{"google-site-verification":"boCWYe21NiraSRAxpceSFH-tJOXQv9ydNotLBHP-S6o","miscellaneous":""},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"BreadcrumbList","@id":"https:\/\/exalon.com\/de\/master-files-cep\/#breadcrumblist","itemListElement":[{"@type":"ListItem","@id":"https:\/\/exalon.com\/de\/#listItem","position":1,"name":"Home","item":"https:\/\/exalon.com\/de\/","nextItem":{"@type":"ListItem","@id":"https:\/\/exalon.com\/de\/master-files-cep\/#listItem","name":"Master Files (ASMF, DMF, PMF), CEP"}},{"@type":"ListItem","@id":"https:\/\/exalon.com\/de\/master-files-cep\/#listItem","position":2,"name":"Master Files (ASMF, DMF, PMF), CEP","previousItem":{"@type":"ListItem","@id":"https:\/\/exalon.com\/de\/#listItem","name":"Home"}}]},{"@type":"Organization","@id":"https:\/\/exalon.com\/de\/#organization","name":"Exalon \u2013 eCTD-Experts","description":"eCTD-Experts","url":"https:\/\/exalon.com\/de\/","telephone":"+4977329391650","logo":{"@type":"ImageObject","url":"https:\/\/exalon.com\/wp-content\/uploads\/Logo_Exalon_slogan_rgb.png","@id":"https:\/\/exalon.com\/de\/master-files-cep\/#organizationLogo","width":853,"height":340},"image":{"@id":"https:\/\/exalon.com\/de\/master-files-cep\/#organizationLogo"}},{"@type":"WebPage","@id":"https:\/\/exalon.com\/de\/master-files-cep\/#webpage","url":"https:\/\/exalon.com\/de\/master-files-cep\/","name":"Master Files (ASMF, DMF, PMF), CEP | Exalon","inLanguage":"de-DE","isPartOf":{"@id":"https:\/\/exalon.com\/de\/#website"},"breadcrumb":{"@id":"https:\/\/exalon.com\/de\/master-files-cep\/#breadcrumblist"},"datePublished":"2018-03-09T11:34:40+01:00","dateModified":"2019-02-19T16:25:37+01:00"},{"@type":"WebSite","@id":"https:\/\/exalon.com\/de\/#website","url":"https:\/\/exalon.com\/de\/","name":"Exalon","description":"eCTD-Experts","inLanguage":"de-DE","publisher":{"@id":"https:\/\/exalon.com\/de\/#organization"}}]},"og:locale":"de_DE","og:site_name":"Exalon | eCTD-Experts","og:type":"article","og:title":"Master Files (ASMF, DMF, PMF), CEP | Exalon","og:url":"https:\/\/exalon.com\/de\/master-files-cep\/","article:published_time":"2018-03-09T10:34:40+00:00","article:modified_time":"2019-02-19T15:25:37+00:00","twitter:card":"summary","twitter:title":"Master Files (ASMF, DMF, PMF), CEP | Exalon"},"aioseo_meta_data":{"post_id":"11","title":null,"description":null,"keywords":null,"keyphrases":null,"primary_term":null,"canonical_url":null,"og_title":null,"og_description":null,"og_object_type":"default","og_image_type":"default","og_image_url":null,"og_image_width":null,"og_image_height":null,"og_image_custom_url":null,"og_image_custom_fields":null,"og_video":null,"og_custom_url":null,"og_article_section":null,"og_article_tags":null,"twitter_use_og":false,"twitter_card":"default","twitter_image_type":"default","twitter_image_url":null,"twitter_image_custom_url":null,"twitter_image_custom_fields":null,"twitter_title":null,"twitter_description":null,"schema":{"blockGraphs":[],"customGraphs":[],"default":{"data":{"Article":[],"Course":[],"Dataset":[],"FAQPage":[],"Movie":[],"Person":[],"Product":[],"ProductReview":[],"Car":[],"Recipe":[],"Service":[],"SoftwareApplication":[],"WebPage":[]},"graphName":"","isEnabled":true},"graphs":[]},"schema_type":null,"schema_type_options":null,"pillar_content":false,"robots_default":true,"robots_noindex":false,"robots_noarchive":false,"robots_nosnippet":false,"robots_nofollow":false,"robots_noimageindex":false,"robots_noodp":false,"robots_notranslate":false,"robots_max_snippet":null,"robots_max_videopreview":null,"robots_max_imagepreview":"large","priority":null,"frequency":null,"local_seo":null,"breadcrumb_settings":null,"limit_modified_date":false,"ai":null,"created":"2021-04-07 13:10:21","updated":"2025-10-08 07:22:08","focus_keyword":null,"additional_keywords":null,"truseo_locale":null,"seo_analyzer_scan_date":null},"_links":{"self":[{"href":"https:\/\/exalon.com\/de\/wp-json\/wp\/v2\/pages\/11","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/exalon.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/exalon.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/exalon.com\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/exalon.com\/de\/wp-json\/wp\/v2\/comments?post=11"}],"version-history":[{"count":5,"href":"https:\/\/exalon.com\/de\/wp-json\/wp\/v2\/pages\/11\/revisions"}],"predecessor-version":[{"id":354,"href":"https:\/\/exalon.com\/de\/wp-json\/wp\/v2\/pages\/11\/revisions\/354"}],"wp:attachment":[{"href":"https:\/\/exalon.com\/de\/wp-json\/wp\/v2\/media?parent=11"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}