{"id":772,"date":"2025-04-23T14:34:19","date_gmt":"2025-04-23T13:34:19","guid":{"rendered":"https:\/\/helsinn.com\/?page_id=772"},"modified":"2025-04-23T16:26:39","modified_gmt":"2025-04-23T15:26:39","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/helsinn.com\/en_us\/technology\/manufacturing-and-supply\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"772\" class=\"elementor elementor-772\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-21b86c1c e-flex e-con-boxed e-con e-parent\" data-id=\"21b86c1c\" 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-2d3434a2 e-con-full e-flex e-con e-child\" data-id=\"2d3434a2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-241a99ec top-title in-pages elementor-widget elementor-widget-heading\" data-id=\"241a99ec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Manufacturing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5fc1f505 e-con-full e-flex e-con e-child\" data-id=\"5fc1f505\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5de56c00 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"5de56c00\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Regulatory Affairs<\/h1>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-67887f53 e-flex e-con-boxed e-con e-parent\" data-id=\"67887f53\" 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<div class=\"elementor-element elementor-element-60ce7547 e-con-full img-dark-overlay e-flex e-con e-child\" data-id=\"60ce7547\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-296c4cab e-con-full e-flex e-con e-child\" data-id=\"296c4cab\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-161b8126 e-con-full elementor-hidden-mobile e-flex e-con e-child\" data-id=\"161b8126\" data-element_type=\"container\" data-e-type=\"container\">\n\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-15f2c460 e-flex e-con-boxed e-con e-parent\" data-id=\"15f2c460\" 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<div class=\"elementor-element elementor-element-20c98f8a e-con-full e-flex e-con e-child\" data-id=\"20c98f8a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5e50c5af elementor-widget elementor-widget-text-editor\" data-id=\"5e50c5af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We hold direct marketing authorizations in the US, EU and China, and have a strong track record of liaising with authorities globally. Regulatory strategies are coordinated centrally not only for the countries where we serve as Marketing Authorization Holder but also for the numerous territories where our Partners hold the authorization. Central alignment and coordination ensures worldwide consistency of our dossiers.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\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-1170fc88 e-flex e-con-boxed e-con e-parent\" data-id=\"1170fc88\" 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-198ee062 e-con-full e-flex e-con e-child\" data-id=\"198ee062\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7b97e135 top-title-card elementor-widget elementor-widget-heading\" data-id=\"7b97e135\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Manufacturing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-38465056 elementor-widget elementor-widget-heading\" data-id=\"38465056\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Supply chain<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33f15ddd elementor-widget elementor-widget-button\" data-id=\"33f15ddd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/helsinn.com\/en_us\/technology\/manufacturing-and-supply\/supply-chain\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Learn more<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-97cc79a e-con-full e-flex e-con e-child\" data-id=\"97cc79a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1c9ed36 top-title-card elementor-widget elementor-widget-heading\" data-id=\"1c9ed36\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Manufacturing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-253adc70 elementor-widget elementor-widget-heading\" data-id=\"253adc70\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Hybrid Manufacturing Approach<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-71e66f7a elementor-widget elementor-widget-button\" data-id=\"71e66f7a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/helsinn.com\/en_us\/technology\/manufacturing-and-supply\/hybrid-manufacturing-approach\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Learn more<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Manufacturing Regulatory Affairs We hold direct marketing authorizations in the US, EU and China, and have a strong track record of liaising with authorities globally. Regulatory strategies are coordinated centrally not only for the countries where we serve as Marketing Authorization Holder but also for the numerous territories where our Partners hold the authorization. Central [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":189,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-772","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages\/772","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/comments?post=772"}],"version-history":[{"count":4,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages\/772\/revisions"}],"predecessor-version":[{"id":841,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages\/772\/revisions\/841"}],"up":[{"embeddable":true,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages\/189"}],"wp:attachment":[{"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/media?parent=772"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}