{"id":2987,"date":"2022-04-06T11:43:49","date_gmt":"2022-04-06T09:43:49","guid":{"rendered":"https:\/\/3bbiotech.com\/regulatory-affairs\/"},"modified":"2025-03-24T11:47:04","modified_gmt":"2025-03-24T10:47:04","slug":"affaires-reglementaires","status":"publish","type":"page","link":"https:\/\/3bbiotech.com\/fr\/affaires-reglementaires\/","title":{"rendered":"Affaires r\u00e8glementaires"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2987\" class=\"elementor elementor-2987 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\/fr\/\">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\">AFFAIRES R\u00c8GLEMENTAIRES <\/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\">Que votre nouveau produit soit un m\u00e9dicament, un dispositif m\u00e9dical, un produit biologique ou m\u00eame une combinaison des deux, nous disposons de l\u2019expertise r\u00e9glementaire \u00e0 jour pour r\u00e9pondre \u00e0 vos exigences sp\u00e9cifiques, tout au long du cycle de vie.<\/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-2988\" 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\">Du d\u00e9veloppement clinique \u00e0 la demande de mise sur le march\u00e9 en passant par les activit\u00e9s post-commercialisation, nos services rationalisent et acc\u00e9l\u00e8rent les parcours pour rendre votre produit disponible sur le march\u00e9 en toute s\u00e9curit\u00e9 et conforme aux l\u00e9gislations applicables aux industries pharmaceutique, biom\u00e9dicale, cosm\u00e9tique et des compl\u00e9ments alimentaires. <\/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\">Nos services Affaires r\u00e8glementaires sont pens\u00e9s pour \u00eatre bas\u00e9s sur la strat\u00e9gie depuis les premi\u00e8res phases du d\u00e9veloppement du produit.<\/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\">Stade de d\u00e9veloppement pr\u00e9coce <\/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>Plans de d\u00e9veloppement strat\u00e9gique<\/li><li>Strat\u00e9gie r\u00e8glementaire<\/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\">D\u00e9veloppement avanc\u00e9 et enregistrement <\/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>Avis scientifique<\/li><li>R\u00e9unions pr\u00e9alables \u00e0 la soumission<\/li><li>Contact avec les autorit\u00e9s sanitaires<\/li><li>ODD (d\u00e9signation de m\u00e9dicament orphelin)\/PIP (plan d\u2019investigation p\u00e9diatrique)<\/li><li>Assistance compl\u00e8te aux demandes d\u2019autorisation de mise sur le march\u00e9<\/li><li>Modifications et renouvellements<\/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\">Assistance au lancement et \u00e0 la post-approbation <\/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>Pr\u00e9paration du lancement<\/li><li>Gestion du cycle de vie<\/li><li>Assistance aux BPF<\/li><li>Assistance \u00e0 l\u2019autorisation de maintenance<\/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\":\"Stade de d\\u00e9veloppement pr\\u00e9coce\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<ul><li>Plans de d\\u00e9veloppement strat\\u00e9gique<\\\/li><li>Strat\\u00e9gie r\\u00e8glementaire<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"D\\u00e9veloppement avanc\\u00e9 et enregistrement\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<ul><li>Avis scientifique<\\\/li><li>R\\u00e9unions pr\\u00e9alables \\u00e0 la soumission<\\\/li><li>Contact avec les autorit\\u00e9s sanitaires<\\\/li><li>ODD (d\\u00e9signation de m\\u00e9dicament orphelin)\\\/PIP (plan d\\u2019investigation p\\u00e9diatrique)<\\\/li><li>Assistance compl\\u00e8te aux demandes d\\u2019autorisation de mise sur le march\\u00e9<\\\/li><li>Modifications et renouvellements<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"Assistance au lancement et \\u00e0 la post-approbation\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<ul><li>Pr\\u00e9paration du lancement<\\\/li><li>Gestion du cycle de vie<\\\/li><li>Assistance aux BPF<\\\/li><li>Assistance \\u00e0 l\\u2019autorisation de maintenance<\\\/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\">Services internationaux<\/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\">Savoir-faire actualis\u00e9 + comp\u00e9tences + exp\u00e9rience 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>Ce m\u00e9lange est essentiel pour fournir un service de haute qualit\u00e9. Nous mettons \u00e0 votre disposition un savoir-faire mondial actualis\u00e9 associ\u00e9 \u00e0 une exp\u00e9rience locale, en combinant des capacit\u00e9s internes et un r\u00e9seau de professionnels de la r\u00e8glementation.<\/p><p>Nos experts sont \u00e9galement des autorit\u00e9s dans le nouveau r\u00e8glement europ\u00e9en sur les essais cliniques actuellement mis en \u0153uvre.<\/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\">Soutien r\u00e9glementaire pour les start-ups<\/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\">Des solutions pour stimuler l\u2019innovation<\/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>\u00cates-vous une start-up qui envisage d\u2019entrer sur le march\u00e9 de l\u2019Union europ\u00e9enne ou d\u2019y d\u00e9velopper son activit\u00e9\u00a0? 3B Biotech peut \u00eatre votre partenaire strat\u00e9gique, pr\u00eat \u00e0 vous aider \u00e0 n\u2019importe quelle \u00e9tape de votre enqu\u00eate.<\/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\">CONSEILS STRAT\u00c9GIQUES<\/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>Nous vous octroyons des conseils strat\u00e9giques pour maximiser la rapidit\u00e9 de mise sur le march\u00e9 de vos produits et planifions tous les aspects r\u00e9glementaires et juridiques pour assurer le plus haut niveau de conformit\u00e9 par rapport \u00e0 la l\u00e9gislation europ\u00e9enne.<\/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\">SOUTIEN R\u00c8GLEMENTAIRE<\/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>Nous g\u00e9rons toutes les activit\u00e9s li\u00e9es \u00e0 l\u2019application et \u00e0 la maintenance de l\u2019AMM, en veillant \u00e0 ce que les exigences r\u00e8glementaires locales au sein de l\u2019UE soient respect\u00e9es et en acc\u00e9l\u00e9rant le d\u00e9lai de mise sur le march\u00e9 de vos produits.<\/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\">AGIR AU NOM DE VOTRE ENTREPRISE  <\/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 agit en votre nom aupr\u00e8s de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) et de l\u2019Autorit\u00e9 nationale comp\u00e9tente pour g\u00e9rer les proc\u00e9dures r\u00e8glementaires.<\/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\">Regulatory affairs for medical device <\/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 may develop a complete project for you or assist your team in the CE marking process, by helping with the increased request for quality clinical data and compliance with the new regulations. Here some duties we may help with:<\/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>Strategic consultancy on the project: feasibility, costs, timing\u00a0<\/li><li>Development and implementation of risk management processes and activities<\/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>Checking and\/or review of the Technical Documentation according to the latest MDR requirements (including clinical assessment, risk analysis, labels and\/or instructions for use)<\/li><li>Organization of the submission with the Notified Body<\/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\">Affaires r\u00e8glementaires pour les produits pharmaceutiques <\/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>Nos solutions sont pens\u00e9es pour \u00eatre orient\u00e9es vers le client et pour faire en sorte que votre d\u00e9veloppement de produit se d\u00e9roule sans heurts.<\/p><p>Voici ci-apr\u00e8s une liste des services cl\u00e9 que nous proposons \u00e0 nos clients\u00a0:<\/p><ul><li>Demandes d\u2019AMM<\/li><li>Transfert d\u2019AMM<\/li><li>Modifications et renouvellements<\/li><li>Gestion du cycle de vie post-approbation<\/li><li>Due diligences<\/li><li>Assistance aux BPF R\u00e9daction technique (ASMF, CTD \/ eCTD)<\/li><li>Gestion des risques<\/li><li>Harmonisation r\u00e8glementaire et proc\u00e9dures de partage des t\u00e2ches.<\/li><\/ul><p>G\u00e9rer les activit\u00e9s li\u00e9es \u00e0 l\u2019application et \u00e0 la maintenance d\u2019AMM, assurer que les exigences r\u00e8glementaires locales au sein de l\u2019UE sont respect\u00e9es et acc\u00e9l\u00e9rer la mise sur le march\u00e9 de vos produits<\/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\">Affaires r\u00e8glementaires pour les produits pharmaceutiques en Suisse<\/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>Mise en place de strat\u00e9gies r\u00e8glementaires<\/li><li>R\u00e9unions et gestion des contacts avec Swissmedic<\/li><li>Pr\u00e9paration de la documentation pour l\u2019autorisation de mise sur le march\u00e9 en Suisse (par ex. demandes de nouvelle substance active, principes actifs connus (PAC) avec ou sans innovation, Art. 13, Art.14 LPTh)<\/li><li>Pr\u00e9paration des formulaires\/documents requis pour le module suisse 1<\/li><li>Pr\u00e9paration de la documentation pour l\u2019autorisation de mise sur le march\u00e9, y compris la compilation eCTD<\/li><li>Pr\u00e9paration de la documentation pour les d\u00e9p\u00f4ts post-autorisation, tels que les modifications, les renouvellements, les changements d\u2019\u00e9tiquetage et les lettres de r\u00e9vision compl\u00e8tes<\/li><li>Gestion des applications dans le portail e-GOV de Swissmedic<\/li><li>Application et soutien en mati\u00e8re de conseils scientifiques avec Swissmedic<\/li><li>Pr\u00e9paration de la documentation pour les d\u00e9p\u00f4ts post-autorisation, tels que les modifications, les extensions, les renouvellements, les changements d\u2019\u00e9tiquetage<\/li><li>Services de traduction de documentation m\u00e9dicale et technique<\/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\u00e9 aux exigences locales -\nNotre r\u00e9seau \n<\/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>Le traitement des proc\u00e9dures europ\u00e9ennes et nationales exige que le titulaire de l\u2019autorisation de mise sur le march\u00e9 (MAH) satisfasse aux exigences au niveau r\u00e9gional. Nous mettons \u00e0 votre disposition un r\u00e9seau de veille r\u00e9glementaire qui vous aide \u00e0 identifier ces exigences et \u00e0 mettre en \u0153uvre un calendrier de travail pour atteindre et maintenir le plus haut niveau de conformit\u00e9.<\/p><p>Voici ci-apr\u00e8s une liste des processus concern\u00e9s\u00a0:<\/p><ul><li>L\u00e9gislation r\u00e8glementaire\u00a0<\/li><li>Service scientifique<\/li><li>Aspects administratifs<\/li><li>Pharmacovigilance<\/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\">Assistance aux BPF<\/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>Notre assistance est fournie avec des experts r\u00e8glementaires ayant une solide exp\u00e9rience en BPF et couvre les sujets suivants\u00a0:\u00a0<\/p><ul><li>\u00e9valuation des fournisseurs de mati\u00e8res premi\u00e8res et de produits finis<\/li><li>audits aupr\u00e8s des fournisseurs de mati\u00e8res premi\u00e8res et de produits finis<\/li><li>\u00e9valuation des processus de production<\/li><li>\u00e9valuation des documents de fabrication<\/li><li>assistance aux probl\u00e8mes de qualit\u00e9<\/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\">Services suppl\u00e9mentaires<\/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>Gr\u00e2ce \u00e0 la synergie avec notre \u00e9quipe clinique et m\u00e9dicale, ainsi qu\u2019\u00e0 une solide exp\u00e9rience, nous pouvons vous soutenir dans des sujets hautement sp\u00e9cifiques, tels que\u00a0:<\/p><ul><li>Avis scientifique<\/li><li>Assistance protocole<\/li><li>D\u00e9signation de m\u00e9dicament orphelin (EMA, FDA)<\/li><li>Plan d\u2019investigation p\u00e9diatrique (PIP)<\/li><li>Demandes d\u2019essais cliniques<\/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\">Services toxicologiques<\/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\" 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=\"MsoNormal\">Gr\u00e2ce \u00e0 un r\u00e9seau qualifi\u00e9, 3B Biotech est en mesure de r\u00e9aliser des \u00e9tudes de toxicit\u00e9 et de mutag\u00e9nicit\u00e9<\/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\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>AFFAIRES R\u00c8GLEMENTAIRES Que votre nouveau produit soit un m\u00e9dicament, un dispositif m\u00e9dical, un produit biologique ou m\u00eame une combinaison des deux, nous disposons de l\u2019expertise r\u00e9glementaire \u00e0 jour pour r\u00e9pondre \u00e0 vos exigences sp\u00e9cifiques, tout au long du cycle de vie. Du d\u00e9veloppement clinique \u00e0 la demande de mise sur le march\u00e9 en passant par &#8230; <a title=\"Affaires r\u00e8glementaires\" class=\"read-more\" href=\"https:\/\/3bbiotech.com\/fr\/affaires-reglementaires\/\" aria-label=\"Read more about Affaires r\u00e8glementaires\">Read more<\/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":[31],"tags":[91],"class_list":{"0":"post-2987","1":"page","2":"type-page","3":"status-publish","5":"category-regulatory-affairs-fr","6":"tag-affaires-reglementaires"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Affaires r\u00e9glementaires | 3B Biotech | Pharmacovigilance<\/title>\n<meta name=\"description\" content=\"Que votre nouveau produit soit un m\u00e9dicament, un dispositif m\u00e9dical, un 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