{"id":2989,"date":"2022-04-06T11:43:49","date_gmt":"2022-04-06T09:43:49","guid":{"rendered":"https:\/\/3bbiotech.com\/regulatory-affairs\/"},"modified":"2025-03-24T11:46:38","modified_gmt":"2025-03-24T10:46:38","slug":"affari-regolatori","status":"publish","type":"page","link":"https:\/\/3bbiotech.com\/it\/affari-regolatori\/","title":{"rendered":"Affari regolatori"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2989\" class=\"elementor elementor-2989 elementor-1235\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-209740f elementor-section-stretched intro-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"209740f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&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-4a5cff5\" data-id=\"4a5cff5\" 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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-592fd4e elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"592fd4e\" 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-50 elementor-inner-column elementor-element elementor-element-16769fe animated-slow elementor-invisible\" data-id=\"16769fe\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\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-5eea623 elementor-widget elementor-widget-shortcode\" data-id=\"5eea623\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><span><span><a href=\"https:\/\/3bbiotech.com\/it\/\">Home<\/a><\/span><\/span><\/div>\n\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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-25ffdcd animated-slow elementor-invisible\" data-id=\"25ffdcd\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-f49dd49 elementor-widget elementor-widget-heading\" data-id=\"f49dd49\" 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\">AFFARI REGOLATORI<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba324c9 elementor-widget elementor-widget-heading\" data-id=\"ba324c9\" 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\">Che il vostro nuovo prodotto sia un farmaco, un dispositivo medico, un prodotto biomedicale o una combinazione di questi, abbiamo le competenze regolatorie pi\u00f9 aggiornate per soddisfare i vostri requisiti specifici, attraverso l'intero ciclo di vita.<\/h2>\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 class=\"elementor-element elementor-element-0b87740 animated-slow elementor-invisible elementor-widget elementor-widget-image\" data-id=\"0b87740\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:800}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1920\" height=\"650\" src=\"https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/Regulatory-Affairs-head-def.jpg\" class=\"attachment-full size-full wp-image-2990\" alt=\"\" srcset=\"https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/Regulatory-Affairs-head-def.jpg 1920w, https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/Regulatory-Affairs-head-def-300x102.jpg 300w, https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/Regulatory-Affairs-head-def-1024x347.jpg 1024w, https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/Regulatory-Affairs-head-def-768x260.jpg 768w, https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/Regulatory-Affairs-head-def-1536x520.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f9a566b elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"f9a566b\" 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-inner-column elementor-element elementor-element-a8b282c animated-slow elementor-invisible\" data-id=\"a8b282c\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-166bdad elementor-widget elementor-widget-heading\" data-id=\"166bdad\" 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\">Dallo sviluppo clinico alla richiesta di commercializzazione e alle attivit\u00e0 post-marketing, i nostri servizi snelliscono e velocizzano i percorsi per rendere il vostro prodotto disponibile sul mercato in modo sicuro e conforme alle normative vigenti che regolano i settori farmaceutico, biomedico, cosmetico e degli integratori alimentari. <\/h2>\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-inner-section elementor-element elementor-element-e26a846 elementor-section-full_width bg-color animated-slow elementor-section-content-middle elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"e26a846\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInUp&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-inner-column elementor-element elementor-element-de3a438\" data-id=\"de3a438\" 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-63b5d7e elementor-widget elementor-widget-heading\" data-id=\"63b5d7e\" 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\">I nostri servizi di Affari Regolatori si basano sulla strategia sin dalle prime fasi di sviluppo del prodotto.<\/h2>\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-inner-section elementor-element elementor-element-ef0f6ad elementor-section-full_width animated-slow elementor-section-content-middle elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"ef0f6ad\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInUp&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-inner-column elementor-element elementor-element-74ecc83\" data-id=\"74ecc83\" 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-2b3f195 elementor-widget elementor-widget-accordion\" data-id=\"2b3f195\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-4531\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-4531\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Sviluppo iniziale<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-4531\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-4531\"><ul><li>Piani di sviluppo strategico<\/li><li>Strategia normativa<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-4532\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-4532\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Sviluppo in fase avanzata e registrazione<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-4532\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-4532\"><ul><li>Consulenza scientifica<\/li><li>Riunioni di pre-presentazione<\/li><li>Collegamento con le autorit\u00e0 sanitarie<\/li><li>ODD\/PIP<\/li><li>Supporto per la richiesta di autorizzazione all&#8217;immissione in commercio<\/li><li>Variazioni e rinnovi<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-4533\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-4533\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Supporto per il lancio e la post-approvazione<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-4533\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-4533\"><ul><li>Preparazione al lancio<\/li><li>Gestione del ciclo di vita<\/li><li>Supporto GMP<\/li><li>Supporto per l&#8217;autorizzazione alla manutenzione<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Sviluppo iniziale\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<ul><li>Piani di sviluppo strategico<\\\/li><li>Strategia normativa<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"Sviluppo in fase avanzata e registrazione\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<ul><li>Consulenza scientifica<\\\/li><li>Riunioni di pre-presentazione<\\\/li><li>Collegamento con le autorit\\u00e0 sanitarie<\\\/li><li>ODD\\\/PIP<\\\/li><li>Supporto per la richiesta di autorizzazione all&#8217;immissione in commercio<\\\/li><li>Variazioni e rinnovi<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"Supporto per il lancio e la post-approvazione\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<ul><li>Preparazione al lancio<\\\/li><li>Gestione del ciclo di vita<\\\/li><li>Supporto GMP<\\\/li><li>Supporto per l&#8217;autorizzazione alla manutenzione<\\\/li><\\\/ul>\"}}]}<\/script>\n\t\t\t\t\t<\/div>\n\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-inner-section elementor-element elementor-element-65455a9 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"65455a9\" 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-inner-column elementor-element elementor-element-fcb3e65 animated-slow elementor-invisible\" data-id=\"fcb3e65\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-bd4fda4 elementor-widget elementor-widget-heading\" data-id=\"bd4fda4\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Servizi internazionali<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4166217 elementor-widget elementor-widget-heading\" data-id=\"4166217\" 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\">Know-how aggiornato + competenze + esperienza locale <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-db53589 elementor-widget elementor-widget-text-editor\" data-id=\"db53589\" 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>Questo mix \u00e8 essenziale per fornire un servizio di alta qualit\u00e0. Vi forniamo un know-how globale aggiornato unito all&#8217;esperienza locale, combinando le capacit\u00e0 interne con una rete di professionisti in Affari regolatori.<\/p><p>I nostri esperti sono anche esperti del nuovo regolamento europeo sulla sperimentazione clinica, attualmente in fase di attuazione.<\/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-inner-section elementor-element elementor-element-68fdbcb elementor-section-full_width elementor-section-content-middle elementor-section-height-default elementor-section-height-default\" data-id=\"68fdbcb\" 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-50 elementor-inner-column elementor-element elementor-element-ea849ce animated-slow img-col elementor-invisible\" data-id=\"ea849ce\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:800,&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-38f9f2d animated-slow elementor-invisible\" data-id=\"38f9f2d\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-69b5ee7 elementor-widget elementor-widget-heading\" data-id=\"69b5ee7\" 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\">Supporto regolatorio per le imprese start-up<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04c70b6 elementor-widget elementor-widget-heading\" data-id=\"04c70b6\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Soluzioni per guidare l'innovazione<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d324e30 elementor-widget elementor-widget-text-editor\" data-id=\"d324e30\" 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>Siete una start-up che sta pianificando di entrare nel mercato dell&#8217;Unione Europea o di espandere la propria attivit\u00e0 al suo interno? 3B Biotech pu\u00f2 essere il vostro partner strategico, pronto ad aiutarvi in qualsiasi fase della vostra ricerca.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20ed5a1 elementor-widget elementor-widget-heading\" data-id=\"20ed5a1\" 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<h4 class=\"elementor-heading-title elementor-size-default\"><span style=\"font-weight: normal\">CONSULENZA STRATEGICA<\/span><\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0d830cb elementor-widget elementor-widget-text-editor\" data-id=\"0d830cb\" 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>Forniamo consulenze strategiche per massimizzare la velocit\u00e0 di commercializzazione dei vostri prodotti e pianifichiamo tutti gli aspetti regolatori e legali per garantire il massimo livello di conformit\u00e0 rispetto alla legislazione europea.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d97840f elementor-widget elementor-widget-heading\" data-id=\"d97840f\" 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<h4 class=\"elementor-heading-title elementor-size-default\"><span style=\"font-weight: normal\">SUPPORTO REGOLATORIO<\/span><\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b2300ae elementor-widget elementor-widget-text-editor\" data-id=\"b2300ae\" 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>Gestiamo tutte le attivit\u00e0 relative all&#8217;applicazione e alla manutenzione della MA, assicurando il rispetto dei requisiti normativi locali all&#8217;interno dell&#8217;UE e accelerando il time to market dei vostri prodotti.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb5b6a9 elementor-widget elementor-widget-heading\" data-id=\"bb5b6a9\" 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<h4 class=\"elementor-heading-title elementor-size-default\"><span style=\"font-weight: 400\">AGIAMO PER CONTO DELLA VOSTRA AZIENDA <\/span><\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-adcab4a elementor-widget elementor-widget-text-editor\" data-id=\"adcab4a\" 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>3B Biotech agisce per vostro conto nei confronti dell&#8217;EMA e dell&#8217;Autorit\u00e0 competente nazionale per gestire le procedure regolatorie.<\/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-inner-section elementor-element elementor-element-c3caab7 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"c3caab7\" 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-inner-column elementor-element elementor-element-cf3f55a animated-slow elementor-invisible\" data-id=\"cf3f55a\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-f8330bc elementor-widget elementor-widget-heading\" data-id=\"f8330bc\" 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\">Affari regolatori per dispositivi medici <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b673b13 elementor-widget elementor-widget-text-editor\" data-id=\"b673b13\" 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>3B Biotech pu\u00f2 sviluppare un progetto completo per voi o assistere il vostro team nel processo di marcatura CE, aiutandovi a soddisfare la crescente richiesta di dati clinici di qualit\u00e0 e di conformit\u00e0 alle nuove normative. Ecco alcuni compiti che possiamo svolgere:<\/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-inner-section elementor-element elementor-element-f9d5419 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"f9d5419\" 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-50 elementor-inner-column elementor-element elementor-element-24e85f7 animated-slow elementor-invisible\" data-id=\"24e85f7\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:750}\">\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-906b56b elementor-widget elementor-widget-text-editor\" data-id=\"906b56b\" 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<ul><li>Consulenza strategica sul progetto: fattibilit\u00e0, costi, tempistica <\/li><li>Sviluppo e implementazione di processi e attivit\u00e0 di gestione del rischio<\/li><\/ul>\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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-db0c6d6 animated-slow elementor-invisible\" data-id=\"db0c6d6\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:1000}\">\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-d122749 elementor-widget elementor-widget-text-editor\" data-id=\"d122749\" 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<ul><li>Controllo e\/o revisione della documentazione tecnica in base ai pi\u00f9 recenti requisiti MDR (compresa la valutazione clinica, l&#8217;analisi dei rischi, le etichette e\/o le istruzioni per l&#8217;uso)<\/li><li>Organizzazione della presentazione con l&#8217;organismo notificato<\/li><\/ul>\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-inner-section elementor-element elementor-element-bfe0632 elementor-section-full_width elementor-section-content-middle elementor-section-height-default elementor-section-height-default\" data-id=\"bfe0632\" 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-50 elementor-inner-column elementor-element elementor-element-952b18b animated-slow elementor-invisible\" data-id=\"952b18b\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-d1ceec6 elementor-widget elementor-widget-heading\" data-id=\"d1ceec6\" 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\">Affari regolatori per il settore farmaceutico <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f2087a elementor-widget elementor-widget-text-editor\" data-id=\"9f2087a\" 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>Le nostre soluzioni sono pensate per essere orientate al cliente e per far s\u00ec che lo sviluppo del prodotto avvenga senza problemi.<\/p><p>Di seguito un elenco dei principali servizi che proponiamo ai nostri clienti:<\/p><ul><li>Applicazioni di MA<\/li><li>Trasferimento di MA<\/li><li>Variazioni e rinnovi<\/li><li>Gestione del ciclo di vita<\/li><li>Due diligences<\/li><li>Supporto GMP<\/li><li>Scrittura tecnica (ASMF, CTD \/ eCTD)<\/li><li>Gestione del rischio<\/li><li>Armonizzazione normativa e procedure di condivisione del lavoro<\/li><\/ul><p>Gestiamo le attivit\u00e0 relative all&#8217;applicazione e al mantenimento della MA, assicurando il rispetto dei requisiti normativi locali all&#8217;interno dell&#8217;UE e accelerando il time to market dei vostri prodotti.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-126e37b elementor-widget elementor-widget-heading\" data-id=\"126e37b\" 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\">Affari regolatori per il settore farmaceutico in Svizzera<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-439b2ac elementor-widget elementor-widget-text-editor\" data-id=\"439b2ac\" 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<ul><li>Impostazione delle strategie normative<\/li><li>Incontri e gestione dei contatti con Swissmedic<\/li><li>Preparazione della documentazione per l&#8217;autorizzazione all&#8217;immissione in commercio in Svizzera (ad es. domande per Nuova sostanza attiva, KAS con o senza innovazione, Art. 13, Art. 14 TPA). 13, Art. 14 TPA)<\/li><li>Preparazione dei moduli\/documenti richiesti per il modulo svizzero 1<\/li><li>Preparazione della documentazione per l&#8217;autorizzazione all&#8217;immissione in commercio, compresa la compilazione di eCTD<\/li><li>Preparazione della documentazione per i depositi successivi all&#8217;autorizzazione, come variazioni, rinnovi, modifiche dell&#8217;etichettatura e lettere di revisione complete.<\/li><li>Gestione delle domande nel portale e-GOV di Swissmedic<\/li><li>Richiesta e supporto in Scientific Advice con Swiss Medic<\/li><li>Preparazione della documentazione per i depositi post-autorizzazione come variazioni, estensioni, rinnovi, modifiche dell&#8217;etichettatura<\/li><li>Servizi di traduzione per la documentazione medica e tecnica<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-153aa85 elementor-widget elementor-widget-heading\" data-id=\"153aa85\" 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\">Conformit\u00e0 ai requisiti locali - <br>Il nostro Network <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0189a98 elementor-widget elementor-widget-text-editor\" data-id=\"0189a98\" 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>La gestione delle procedure europee e nazionali richiede che la MAH soddisfi i requisiti a livello regionale. Vi forniamo una rete di &#8220;Regulatory Intelligence&#8221; che vi aiuta a identificare tali requisiti e a implementare un programma di lavoro per raggiungere e mantenere il massimo livello di conformit\u00e0.<\/p><p>Di seguito un elenco dei processi interessati:<\/p><ul><li>Legislazione normativa<\/li><li>Servizio scientifico<\/li><li>Aspetti amministrativi<\/li><li>Farmacovigilanza<\/li><\/ul>\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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-72490a2 animated-slow img-col elementor-invisible\" data-id=\"72490a2\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:800,&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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-inner-section elementor-element elementor-element-0355c78 elementor-section-full_width elementor-section-content-middle elementor-section-height-default elementor-section-height-default\" data-id=\"0355c78\" 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-50 elementor-inner-column elementor-element elementor-element-889544b animated-slow img-col elementor-invisible\" data-id=\"889544b\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:800,&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-df6c8e5 animated-slow elementor-invisible\" data-id=\"df6c8e5\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-8b8901b elementor-widget elementor-widget-heading\" data-id=\"8b8901b\" 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\">Supporto GMP<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26cabfb elementor-widget elementor-widget-text-editor\" data-id=\"26cabfb\" 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>Il nostro supporto \u00e8 fornito da esperti di regolamentazione con un solido background GMP e copre i seguenti argomenti:<\/p><ul><li>Valutazione dei fornitori di materie prime e prodotti finiti<\/li><li>Audit ai fornitori di materie prime e prodotti finiti<\/li><li>Valutazione dei processi di produzione<\/li><li>Valutazione dei documenti di produzione<\/li><li>Supporto per le questioni di qualit\u00e0<\/li><\/ul>\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-inner-section elementor-element elementor-element-b550c98 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"b550c98\" 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-inner-column elementor-element elementor-element-2c934a7 animated-slow elementor-invisible\" data-id=\"2c934a7\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-72320b5 elementor-widget elementor-widget-heading\" data-id=\"72320b5\" 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\">Servizi aggiuntivi<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2531c11 elementor-widget elementor-widget-text-editor\" data-id=\"2531c11\" 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>Grazie alla sinergia con il nostro team clinico e medico, oltre che a una solida esperienza, siamo in grado di supportarvi su temi altamente specifici, quali:<\/p><ul><li>Consulenza scientifica<\/li><li>Assistenza al protocollo<\/li><li>Designazione di farmaco orfano (EMA, FDA)<\/li><li>Piano di Indagine Pediatrica (PIP)<\/li><li>Richieste di sperimentazione clinica<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9158347 elementor-widget elementor-widget-heading\" data-id=\"9158347\" 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\">Servizi tossicologico<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52335ce elementor-widget elementor-widget-text-editor\" data-id=\"52335ce\" data-element_type=\"widget\" data-e-type=\"widget\" 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Dallo sviluppo clinico alla richiesta di commercializzazione e alle attivit\u00e0 post-marketing, i nostri servizi snelliscono e velocizzano &#8230; <a title=\"Affari regolatori\" class=\"read-more\" href=\"https:\/\/3bbiotech.com\/it\/affari-regolatori\/\" aria-label=\"Read more about Affari regolatori\">Leggi tutto<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"content-type":"","footnotes":""},"categories":[32],"tags":[64],"class_list":{"0":"post-2989","1":"page","2":"type-page","3":"status-publish","5":"category-affari-regolatori","6":"tag-affari-regolatori"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Affari Regolatori | 3B Biotech | Servizi di Farmacovigilanza<\/title>\n<meta name=\"description\" content=\"Che il vostro nuovo prodotto sia un farmaco, abbiamo le competenze 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