{"id":10414,"date":"2024-03-11T10:25:50","date_gmt":"2024-03-11T08:25:50","guid":{"rendered":"https:\/\/adragos-pharma.com\/?page_id=10414"},"modified":"2025-09-02T16:57:29","modified_gmt":"2025-09-02T14:57:29","slug":"services-de-reglementation","status":"publish","type":"page","link":"https:\/\/adragos-pharma.com\/fr\/nos-services\/services-de-reglementation\/","title":{"rendered":"Services de R\u00e9glementation\u00a0"},"content":{"rendered":"\n<section class=\"wp-block-adragos-blocks-header relative has-primary-background-color bg-pattern bg-cover max-w-full bg-bottom px-3 pt-10 pb-44 md:pt-16 md:pb-44 has-background\"><div class=\"relative z-30 max-w-screen-xl px-6 m-auto\"><nav class=\"flex mb-4\" aria-label=\"Breadcrumb\"><ol class=\"inline-flex items-center space-x-1 md:space-x-2 rtl:space-x-reverse\"><li class=\"inline-flex items-center\"><a href=\"https:\/\/adragos-pharma.com\/fr\/\" class=\"inline-flex items-center text-sm font-medium text-white hover:text-primary\"><svg class=\"w-3 h-3 me-2.5\" aria-hidden=\"true\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" fill=\"currentColor\" viewBox=\"0 0 20 20\"><path d=\"m19.707 9.293-2-2-7-7a1 1 0 0 0-1.414 0l-7 7-2 2a1 1 0 0 0 1.414 1.414L2 10.414V18a2 2 0 0 0 2 2h3a1 1 0 0 0 1-1v-4a1 1 0 0 1 1-1h2a1 1 0 0 1 1 1v4a1 1 0 0 0 1 1h3a2 2 0 0 0 2-2v-7.586l.293.293a1 1 0 0 0 1.414-1.414Z\"><\/path><\/svg>Home<\/a><\/li><li><div class=\"flex items-center\"><svg class=\"rtl:rotate-180 w-3 h-3 text-white mx-1\" aria-hidden=\"true\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" fill=\"none\" viewBox=\"0 0 6 10\"><path stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" d=\"m1 9 4-4-4-4\"><\/path><\/svg><a href=\"https:\/\/adragos-pharma.com\/fr\/nos-services\/\" class=\"ms-1 text-sm font-medium text-white hover:text-primary md:ms-2\">Nos Services<\/a><\/div><\/li><li class=\"hidden md:inline-block\" aria-current=\"page\"><div class=\"flex items-center\"><svg class=\"rtl:rotate-180 w-3 h-3 text-white mx-1\" aria-hidden=\"true\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" fill=\"none\" viewBox=\"0 0 6 10\"><path stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" d=\"m1 9 4-4-4-4\"><\/path><\/svg><span class=\"ms-1 text-sm font-medium text-white md:ms-2\">Services de R\u00e9glementation\u00a0<\/span><\/div><\/li><\/ol><\/nav><h1 class=\"text-3xl md:text-4xl text-white\">Services de R\u00e9glementation\u00a0<\/h1><\/div><div class=\"bg-wave absolute left-0 bottom-0 h-52 bg-repeat-x bg-[center_bottom] w-full\"><\/div><\/section>\n\n\n\n<div class=\"wp-block-columns max-w-screen-xl w-full is-wide px-0 md:px-8 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p>L&rsquo;industrie pharmaceutique se caract\u00e9rise par sa nature dynamique, avec des changements constants dans les cadres r\u00e9glementaires et les secteurs de la sant\u00e9. Ce paysage exige des conseils r\u00e9glementaires experts tout au long des processus de d\u00e9veloppement et d&rsquo;enregistrement des produits de sant\u00e9.&nbsp;<\/p>\n\n\n\n<p>Ma\u00eetrisant les derniers changements r\u00e9glementaires internationaux, notre \u00e9quipe se consacre \u00e0 offrir un soutien in\u00e9gal\u00e9, en particulier dans les domaines des soumissions et de la documentation.&nbsp;<\/p>\n\n\n\n<p>Toutes nos installations sont certifi\u00e9es selon les normes BPF de l&rsquo;UE et agissent en conformit\u00e9 avec les r\u00e9glementations de la FDA des \u00c9tats-Unis, en particulier :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>notre site suisse est reconnu par la r\u00e9glementation BPF de <strong>Swissmedic<\/strong><\/li>\n\n\n\n<li>notre site japonais est reconnu par le <strong>PMDA<\/strong><\/li>\n\n\n\n<li>notre site fran\u00e7ais est reconnu par l&rsquo;<strong>ANSM<\/strong> BPF (Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9), l&rsquo;<strong>ANSES<\/strong> (Agence de s\u00e9curit\u00e9 sanitaire de l&rsquo;alimentation, de l&rsquo;environnement et du travail) et par la <strong>KFDA <\/strong>(Korea Food and Drug Administration)<\/li>\n\n\n\n<li>notre site allemand b\u00e9n\u00e9ficie d&rsquo;une autorisation de fabrication conform\u00e9ment \u00e0 la loi sur les m\u00e9dicaments (Arzneimittelgesetz &#8211; <strong>AMG<\/strong>)<\/li>\n<\/ul>\n\n\n\n<p>&nbsp;<\/p>\n\n\n\n<section class=\"wp-block-adragos-blocks-box max-w-screen-xl mx-auto px-8 py-8\"><div class=\"grid grid-cols-1 lg:grid-cols-2 gap-x-8 gap-y-8\"><div class=\"false relative box bg-light rounded-xl p-8\"><div class=\"flex gap-5 items-center\"><img decoding=\"async\" class=\"box-image mb-0\" src=\"https:\/\/adragos-pharma.com\/wp-content\/uploads\/2024\/03\/Regulatory-Services.png\" alt=\"\"\/><h3 class=\"box-title\">Services de r\u00e9glementation\u00a0<\/h3><\/div><p class=\"my-6 box-subtitle\">\u2022 Contr\u00f4le continu tout au long du processus de d\u00e9veloppement&nbsp;<br>\u2022 \u00c9valuation des informations et de la documentation r\u00e9glementaires en vue de la constitution d&rsquo;un dossier d&rsquo;enregistrement conforme aux normes les plus strictes&nbsp;<br>\u2022 Examen et \u00e9valuation des donn\u00e9es administratives&nbsp;&nbsp;&nbsp;<br>\u2022 R\u00e9daction de rapports scientifiques&nbsp;<br>\u2022 Rapports d&rsquo;\u00e9valuation des risques (par exemple, nitrosamines, impuret\u00e9s \u00e9l\u00e9mentaires (Q3D))&nbsp;<br>\u2022 Compilation et organisation des donn\u00e9es pour les rapports de pr\u00e9-soumission\/conseils scientifiques&nbsp;<br>\u2022 D\u00e9signation d&rsquo;une strat\u00e9gie r\u00e9glementaire&nbsp;<br>\u2022 Liaison avec les autorit\u00e9s r\u00e9glementaires europ\u00e9ennes pour les soumissions, les demandes de renseignements, les modifications et les renouvellements&nbsp;&nbsp;&nbsp;<br>\u2022 Soumissions \u00e9lectroniques (demandes, modifications, renouvellements, lettres de carence des clients\/autorit\u00e9s) e-CTD&nbsp;<br>\u2022 Enregistrement de produits pharmaceutiques par le biais de proc\u00e9dures nationales, de reconnaissance mutuelle et d\u00e9centralis\u00e9es&nbsp;<\/p><\/div><div class=\"false relative box bg-light rounded-xl p-8\"><div class=\"flex gap-5 items-center\"><img decoding=\"async\" class=\"box-image mb-0\" src=\"https:\/\/adragos-pharma.com\/wp-content\/uploads\/2024\/04\/Expertise-green.png\" alt=\"\"\/><h3 class=\"box-title\">Points forts\u00a0<\/h3><\/div><p class=\"my-6 box-subtitle\">\u2022 Plus de 100 soumissions en Europe&nbsp;&nbsp;<br>\u2022 Plus de 200 AMM (autorisation de mise sur le march\u00e9) dans plus de 20 pays&nbsp;<br>\u2022 Une grande exp\u00e9rience des applications complexes des bases l\u00e9gales hybrides (10.3) et bibliographiques (10a)&nbsp;&nbsp;&nbsp;<br>\u2022 Soumissions \u00e9lectroniques utilisant le gestionnaire eCTD d&rsquo;EXTEDO&nbsp;&nbsp;&nbsp;<br>\u2022 Plus de 20 r\u00e9unions de conseil scientifique avec les autorit\u00e9s europ\u00e9ennes (y compris l&rsquo;EMA)&nbsp;<\/p><\/div><\/div><\/section>\n<\/div>\n<\/div><style>\n            .wp-block-columns.is-wide {\n\t\t\t\tmax-width: 1280px!important;\n\t\t\t\tmargin-left: auto!important;\n\t\t\t\tmargin-right: auto!important;\n            }\n        <\/style>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-columns max-w-screen-xl w-full is-wide px-0 md:px-8 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\t<div class=\"tw-flex-col md:tw-flex-row tw-flex tw-justify-center\">\n\t\t<div class=\"tw-flex md:tw-flex tw-flex-col tw-shrink-0 tw-pr-12\">\n\t\t\t<h2>D\u00e9couvrez nos experts<\/h2>\n\t\t\t<p class=\"md:tw-max-w-72 xl:tw-text-lg md:tw-text-base tw-font-normal\">\n\t\t\t\tHautement qualifi\u00e9s et exp\u00e9riment\u00e9s dans leur domaine.\t\t\t<\/p>\n\t\t\t\t\t<\/div>\n\t\t<div class=\"no-slider\">\n\t\t\t<div class=\"tw-flex tw-flex-col md:tw-flex-row tw-gap-6\">\n\t\t\t\t\t\t\t\t\t<a data-id=\"2909\" href=\"https:\/\/adragos-pharma.com\/fr\/team\/lenia-papadimou\/\" class=\"tw-relative tw-overflow-hidden \">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/adragos-pharma.com\/wp-content\/uploads\/2024\/03\/Lenia-Papadimou-560x680.jpg\" alt=\"Lenia Papadimou\" class=\"!tw-mb-0 tw-rounded-xl tw-object-cover tw-w-full tw-h-full\" \/>\n\t\t\t\t\t\t<div class=\"custom tw-absolute tw-bottom-0\">\n\t\t\t\t\t\t\t<div class=\"tw-relative tw-z-10 tw-w-full tw-pl-6 tw-pr-9\">\n\t\t\t\t\t\t\t\t<h3 class=\"!tw-text-white tw-text-xl tw-font-bold hover:!tw-text-secondary !tw-mb-0\">Lenia Papadimou<\/h3>\n\t\t\t\t\t\t\t\t<p class=\"!tw-text-white tw-text-base tw-font-normal tw-pt-3 tw-pb-7 !tw-mb-0\">Head of Regulatory Affairs, Athens<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"glass-effect\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n\t\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n        <section class=\"tw-mx-auto tw-max-w-screen-xl tw-px-8 tw-py-20\">\n            <header class=\"tw-flex tw-flex-col md:tw-flex-row lg:tw-items-center tw-justify-between tw-pb-20\">\n                <h2 class=\"tw-flex tw-gap-3 text-secondary tw-items-center lg:tw-w-1\/3 lg:tw-pr-12 tw-mb-6\">\n                    <svg width=\"27\" height=\"3\" viewBox=\"0 0 27 3\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                        <rect width=\"27\" height=\"3\" fill=\"#8696FE\" \/>\n                    <\/svg>\n                    <a href=\"\">Adragos Hub<\/a>\n                <\/h2>\n                <p class=\"font-RobotoSlab tw-text-lg xl:tw-text-xl tw-font-light lg:tw-w-2\/3 lg:tw-pl-32\">\n                    En savoir plus sur les services r\u00e9glementaires dans nos articles de blog r\u00e9cents.                <\/p>\n            <\/header>\n\t\t\t<div class=\"tw-grid tw-grid-cols-1 lg:tw-grid-cols-2 tw-gap-6\">\n\t\t\t\t\t\t\t\t\t<div class=\"tw-relative tw-rounded-xl tw-overflow-hidden tw-min-h-60 tw-mb-6\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/adragos-pharma.com\/wp-content\/uploads\/2025\/03\/Visuals-for-the-Kawagoe-webinar-1-for-web.jpg\" alt=\"Comment p\u00e9n\u00e9trer le march\u00e9 japonais [webinaire]\" class=\"tw-object-cover tw-absolute\" \/>\n\t\t\t\t\t\t<div class=\"tw-absolute tw-bottom-0 tw-max-w-96 tw-bg-lightslate tw-backdrop-blur-[12px] tw-p-6 tw-rounded-tr-xl tw-w-full\">\n\t\t\t\t\t\t\t<p class=\"text-primary tw-text-xs tw-font-medium tw-tracking-widest tw-uppercase tw-pb-1\">Ressources<\/p>\n\t\t\t\t\t\t\t<h3 class=\"tw-text-white tw-text-lg hover:tw-underline\">\n\t\t\t\t\t\t\t\t<a href=\"https:\/\/adragos-pharma.com\/fr\/comment-penetrer-le-marche-japonais-webinaire\/\">Comment p\u00e9n\u00e9trer le march\u00e9 japonais [webinaire]<\/a>\n\t\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"tw-relative tw-rounded-xl tw-overflow-hidden tw-min-h-60 tw-mb-6\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/adragos-pharma.com\/wp-content\/uploads\/2024\/09\/3Q4A7591-1024x480.jpg\" alt=\"M\u00e9dicaments g\u00e9n\u00e9riques vs de marque : diff\u00e9rences expliqu\u00e9es\" class=\"tw-object-cover tw-absolute\" \/>\n\t\t\t\t\t\t<div class=\"tw-absolute tw-bottom-0 tw-max-w-96 tw-bg-lightslate tw-backdrop-blur-[12px] tw-p-6 tw-rounded-tr-xl tw-w-full\">\n\t\t\t\t\t\t\t<p class=\"text-primary tw-text-xs tw-font-medium tw-tracking-widest tw-uppercase tw-pb-1\">Blog<\/p>\n\t\t\t\t\t\t\t<h3 class=\"tw-text-white tw-text-lg hover:tw-underline\">\n\t\t\t\t\t\t\t\t<a href=\"https:\/\/adragos-pharma.com\/fr\/medicaments-generiques-vs-de-marque-differences-expliquees\/\">M\u00e9dicaments g\u00e9n\u00e9riques vs de marque : diff\u00e9rences expliqu\u00e9es<\/a>\n\t\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"tw-relative tw-rounded-xl tw-overflow-hidden tw-min-h-60 tw-mb-6\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/adragos-pharma.com\/wp-content\/uploads\/2024\/08\/ADRAGOS_Livron-20-1024x480.jpg\" alt=\"Injectables st\u00e9riles : consid\u00e9rations cl\u00e9s pour l\u2019industrie pharma\" class=\"tw-object-cover tw-absolute\" \/>\n\t\t\t\t\t\t<div class=\"tw-absolute tw-bottom-0 tw-max-w-96 tw-bg-lightslate tw-backdrop-blur-[12px] tw-p-6 tw-rounded-tr-xl tw-w-full\">\n\t\t\t\t\t\t\t<p class=\"text-primary tw-text-xs tw-font-medium tw-tracking-widest tw-uppercase tw-pb-1\">Blog<\/p>\n\t\t\t\t\t\t\t<h3 class=\"tw-text-white tw-text-lg hover:tw-underline\">\n\t\t\t\t\t\t\t\t<a href=\"https:\/\/adragos-pharma.com\/fr\/injectables-steriles-considerations-cles-pour-lindustrie-pharma\/\">Injectables st\u00e9riles : consid\u00e9rations cl\u00e9s pour l\u2019industrie pharma<\/a>\n\t\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"tw-relative tw-rounded-xl tw-overflow-hidden tw-min-h-60 tw-mb-6\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/adragos-pharma.com\/wp-content\/uploads\/2024\/08\/3Q4A7207-1024x480.jpg\" alt=\"Produit vs substance m\u00e9dicamenteuse : diff\u00e9rences essentielles\" class=\"tw-object-cover tw-absolute\" \/>\n\t\t\t\t\t\t<div class=\"tw-absolute tw-bottom-0 tw-max-w-96 tw-bg-lightslate tw-backdrop-blur-[12px] tw-p-6 tw-rounded-tr-xl tw-w-full\">\n\t\t\t\t\t\t\t<p class=\"text-primary tw-text-xs tw-font-medium tw-tracking-widest tw-uppercase tw-pb-1\">Blog<\/p>\n\t\t\t\t\t\t\t<h3 class=\"tw-text-white tw-text-lg hover:tw-underline\">\n\t\t\t\t\t\t\t\t<a href=\"https:\/\/adragos-pharma.com\/fr\/produit-vs-substance-medicamenteuse-differences-essentielles\/\">Produit vs substance m\u00e9dicamenteuse : diff\u00e9rences essentielles<\/a>\n\t\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\n        <\/section>\n        \n<\/div>\n<\/div><style>\n            .wp-block-columns.is-wide {\n\t\t\t\tmax-width: 1280px!important;\n\t\t\t\tmargin-left: auto!important;\n\t\t\t\tmargin-right: auto!important;\n            }\n        <\/style>\n\n\n\n<div class=\"wp-block-columns max-w-screen-xl w-full is-wide px-0 md:px-8 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<section class=\"wp-block-adragos-blocks-footer-cta max-w-screen-lg bg-light mx-8 md:mx-auto px-8 py-12 text-center mt-3 mb-12 md:mb-16 rounded-xl\"><h2 class=\"\">Contactez-Nous\u00a0<\/h2><p class=\"subtitle font-light m-auto max-w-screen-sm py-6\">Pour plus de d\u00e9tails sur notre entreprise et nos services, n&rsquo;h\u00e9sitez pas \u00e0 contacter notre \u00e9quipe.\u00a0<\/p><div class=\"flex flex-col md:flex-row justify-center gap-4\"><a href=\"https:\/\/adragos-pharma.com\/fr\/nous-contacter\/?utm_campaign=MK_website_contactUs&#038;utm_source=Google&#038;utm_medium=banner&#038;utm_term=french&#038;utm_content=contact_us\" class=\"cta-link inline-block adragos-button text-white has-primary-background-color text-center\">Envoyer un message\u00a0<\/a><a href=\"https:\/\/meetings-eu1.hubspot.com\/lydia-marinou?ref=regulatory-services-fr-button\" class=\"cta-link2 inline-block adragos-button text-white has-secondary-background-color text-center\" target=\"_blank\" rel=\"noopener\">Planifier une r\u00e9union<\/a><\/div><\/section>\n<\/div>\n<\/div><style>\n            .wp-block-columns.is-wide {\n\t\t\t\tmax-width: 1280px!important;\n\t\t\t\tmargin-left: auto!important;\n\t\t\t\tmargin-right: auto!important;\n            }\n        <\/style>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>L&rsquo;industrie pharmaceutique se caract\u00e9rise par sa nature dynamique, avec des changements constants dans les cadres r\u00e9glementaires et les secteurs de la sant\u00e9. Ce paysage exige des conseils r\u00e9glementaires experts tout au long des processus de d\u00e9veloppement et d&rsquo;enregistrement des produits [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"parent":10441,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"content-type":"","inline_featured_image":false,"footnotes":""},"class_list":["post-10414","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/pages\/10414","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/comments?post=10414"}],"version-history":[{"count":16,"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/pages\/10414\/revisions"}],"predecessor-version":[{"id":22274,"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/pages\/10414\/revisions\/22274"}],"up":[{"embeddable":true,"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/pages\/10441"}],"wp:attachment":[{"href":"https:\/\/adragos-pharma.com\/fr\/wp-json\/wp\/v2\/media?parent=10414"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}