{"id":4467,"date":"2026-06-08T13:06:22","date_gmt":"2026-06-08T13:06:22","guid":{"rendered":"https:\/\/viewscience.it\/regulatory-affairs\/"},"modified":"2026-06-09T11:19:08","modified_gmt":"2026-06-09T11:19:08","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/viewscience.it\/en\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4467\" class=\"elementor elementor-4467 elementor-4312\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3032365 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"3032365\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8e1f21a\" data-id=\"8e1f21a\" 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-595c442 elementor-widget elementor-widget-heading\" data-id=\"595c442\" 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\">Regulatory Affairs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d868808 elementor-align-center elementor-mobile-align-center elementor-widget elementor-widget-button\" data-id=\"d868808\" 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:\/\/viewscience.it\/servizi-consulenza-scientifica-regolatoria\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M7 17L17 7M17 7H8M17 7V16\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Back to full list of activities<\/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\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-cdb6843 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"cdb6843\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d3b7272\" data-id=\"d3b7272\" 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-2167111 elementor-widget elementor-widget-heading\" data-id=\"2167111\" 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\">Pharmaceutical Regulatory Affairs Consulting<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d660c96 elementor-widget elementor-widget-text-editor\" data-id=\"d660c96\" 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>Pharmaceutical <em>regulatory affairs<\/em> consulting requires precise technical skills, up-to-date knowledge of AIFA and EMA regulations, and the ability to translate complex requirements into concrete actions. View Science supports pharmaceutical, biotech, and life sciences companies at <strong>every stage of the regulatory pathway-from<\/strong> initial strategy through post-authorization maintenance-with an <strong>integrated approach<\/strong> that combines scientific rigor and communicative clarity.<\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c61431a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c61431a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-55864df\" data-id=\"55864df\" 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-02fb46d elementor-widget elementor-widget-heading\" data-id=\"02fb46d\" 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\">Marketing authorization (MA) and eCTD dossier management.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67d5067 elementor-widget elementor-widget-text-editor\" data-id=\"67d5067\" 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 class=\"content-p\">The process of obtaining Marketing Authorization (MA) is the heart of pharmaceutical regulatory activity. View Science supports companies in <strong>preparing<\/strong> and <strong>submitting<\/strong> dossiers in eCTD (electronic Common Technical Document) format, ensuring compliance with ICH standards and the requirements of the relevant <a href=\"https:\/\/www.aifa.gov.it\">agencies-AIFA<\/a> for the Italian market, <a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\">EMA<\/a> for European centralized procedures.<\/p><p class=\"content-p\">Our support includes:<\/p><ul class=\"content-ul\"><li>Regulatory <strong>feasibility analysis<\/strong> and definition of registration strategy<\/li><li><strong>Preparation and formatting<\/strong> of the dossier in CTD\/eCTD format<\/li><li><strong>Management of national<\/strong>, mutual recognition <strong>procedures<\/strong>(MRP) and decentralized <strong>procedures<\/strong>(DCP).<\/li><li><strong>Coordination of responses<\/strong> to requests for clarification (Day 70\/120\/150\/180)<\/li><li><strong>Management of AIC variations<\/strong> and post-approval regulatory lifecycle<\/li><\/ul><p> <\/p><p>We work both with Companies facing the authorization pathway for the first time and with structured entities that need operational support on high volumes of files or on highly complex products such as <strong>orphan drugs, ATMPs, and biotechnology.<\/strong><\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-066233f elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"066233f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-cc757a2\" data-id=\"cc757a2\" 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-82a6259 elementor-mobile-align-justify elementor-align-center elementor-widget elementor-widget-button\" data-id=\"82a6259\" 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:\/\/viewscience.it\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M7 17L17 7M17 7H8M17 7V16\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">DO YOU ALREADY HAVE QUESTIONS?<\/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\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-8be29cf elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8be29cf\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-84ec60d\" data-id=\"84ec60d\" 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-b4da786 elementor-widget elementor-widget-heading\" data-id=\"b4da786\" 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\">Regulatory intelligence and integrated regulatory strategy<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7a3939 elementor-widget elementor-widget-text-editor\" data-id=\"d7a3939\" 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 class=\"content-p\">The pharmaceutical regulatory landscape is <strong>constantly evolving<\/strong>: new EMA regulations, updates to ICH guidelines, revision of AIFA procedures, and the introduction of European HTA Regulation 2021\/2282 are constantly redefining the environment in which Companies operate. View Science offers a <strong>Regulatory Intelligence<\/strong> service to monitor relevant regulatory changes and translate them into concrete opportunities or actions for your product portfolio.<\/p><p class=\"content-p\">Our approach sets View Science apart in the Italian regulatory consulting landscape: we do not just manage document compliance, but <strong>integrate regulatory strategy with market access, HTA, and scientific communication activities.<\/strong> This means that every dossier, every variation, and every interaction with authorities is also designed taking into account the market access pathway and the value the product has to communicate to payers, clinicians, and institutions.<\/p><p class=\"content-p\">We operate with a <strong>dedicated team<\/strong> model for each Client, built on the specific skills required by the project. We work in synergy to provide quality service at <strong>every stage of the product life cycle.<\/strong><\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-54a7cc6 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"54a7cc6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-67175d9\" data-id=\"67175d9\" 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-c3055b8 elementor-widget elementor-widget-text-editor\" data-id=\"c3055b8\" 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>Planning a new registration, managing an existing portfolio, or need regulatory support on a specific product? <a href=\"https:\/\/viewscience.it\/contact\/\"><span style=\"text-decoration: underline;\"><strong>Contact us for a cognitive call<\/strong> <strong>free of charge<\/strong><\/span><\/a> \u2013 We will assess your needs together and propose a tailored path.<\/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>Regulatory Affairs Back to full list of activities Pharmaceutical Regulatory Affairs Consulting Pharmaceutical regulatory affairs consulting requires precise technical skills, up-to-date knowledge of AIFA and EMA regulations, and the ability to translate complex requirements into concrete actions. View Science supports pharmaceutical, biotech, and life sciences companies at every stage of the regulatory pathway-from initial strategy [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4467","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmaceutical Regulatory Affairs Consulting | eCTD | View Science<\/title>\n<meta name=\"description\" content=\"Support in pharmaceutical Regulatory Affairs: preparation of AIC dossier, eCTD. 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