{"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":[],"_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}]}}