{"id":2840,"date":"2026-10-28T21:40:09","date_gmt":"2026-10-28T20:40:09","guid":{"rendered":"https:\/\/pharegistrum.com\/?page_id=2840"},"modified":"2026-10-28T21:40:15","modified_gmt":"2026-10-28T20:40:15","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/pharegistrum.com\/en\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs Consultancy"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2840\" class=\"elementor elementor-2840 elementor-2839\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d9a90b elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"6d9a90b\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b8604cb\" data-id=\"b8604cb\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2a5e462 elementor-widget__width-initial animated-slow elementor-widget elementor-widget-heading\" data-id=\"2a5e462\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&quot;}\" 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 Consultancy<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9a92740 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9a92740\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7d6afba\" data-id=\"7d6afba\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-phseotxt elementor-widget elementor-widget-text-editor\" data-id=\"phseotxt\" 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>Pharegistrum supports companies with regulatory strategy, documentation and product procedures before the relevant authorities. Based in Lisbon and operating since 2007, we provide pharmaceutical and technical consultancy tailored to the product and stage of the project.<\/p><h2>From regulatory strategy to product registration<\/h2><p>Our support can begin before an application is submitted and continue through registration maintenance. We prepare documentation and liaise with regulatory authorities on behalf of clients.<\/p><ul><li>Regulatory strategy and preparation of marketing authorisation dossiers, including eCTD.<\/li><li>Product registration with bodies such as INFARMED, DGAV, DGS, ECHA, CPNP and CIAV, depending on the product.<\/li><li>Registration maintenance: variations, renewals and updates.<\/li><li>Preparation and review of labelling, package leaflets and advertising materials.<\/li><\/ul><h2>Support for different product categories<\/h2><p>Our services cover medicines, medical devices, food supplements, cosmetics, veterinary products, biocides and detergents. The scope of each project is defined according to the product.<\/p><ul><li>Medical devices: support with CE marking and technical dossiers.<\/li><li>Cosmetics: preparation of product information files (PIFs).<\/li><li>Veterinary products: authorisation and registration applications.<\/li><li>Preparation of safety data sheets and applications for CNP codes.<\/li><\/ul><h2>Starting your regulatory project<\/h2><p>Tell us about the product, intended markets, available documentation and current project stage. This helps us define the scope of support and prepare a proposal suited to your needs.<\/p><p><a href=\"\/en\/contact\/\">Request a proposal<\/a> \u00b7 <a href=\"\/en\/services\/\">Explore all services<\/a><\/p>\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Pharegistrum supports companies with regulatory strategy, documentation and product procedures before the relevant authorities. Based in Lisbon and operating since 2007, we provide pharmaceutical and technical consultancy tailored to the product and stage of the project. From regulatory strategy to product registration Our support can begin before an application is submitted and continue through registration [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-2840","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/pages\/2840","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/comments?post=2840"}],"version-history":[{"count":1,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/pages\/2840\/revisions"}],"predecessor-version":[{"id":2845,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/pages\/2840\/revisions\/2845"}],"wp:attachment":[{"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/media?parent=2840"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}