{"id":5977,"date":"2024-05-24T12:06:27","date_gmt":"2024-05-24T10:06:27","guid":{"rendered":"https:\/\/www.universalmedica.com\/affaires-reglementaires\/"},"modified":"2024-05-24T13:07:08","modified_gmt":"2024-05-24T11:07:08","slug":"affaires-reglementaires","status":"publish","type":"page","link":"https:\/\/www.universalmedica.com\/en\/affaires-reglementaires\/","title":{"rendered":"Regulatory affairs"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5977\" class=\"elementor elementor-5977 elementor-5972\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-eff1687 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"eff1687\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ac7af5b\" data-id=\"ac7af5b\" 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-f14b876 elementor-widget elementor-widget-slider_revolution\" data-id=\"f14b876\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"slider_revolution.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n\t\t<div id=\"regulatory-slider\" class=\"wp-block-themepunch-revslider\">\n\t\t\t\t<p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t\t<sr7-module data-alias=\"slider-home\" data-id=\"1\" id=\"SR7_1_1\" class=\"rs-ov-hidden\" data-version=\"6.7.52\">\n\t\t\t\t\t<sr7-adjuster><\/sr7-adjuster>\n\t\t\t\t\t<sr7-content>\n\t\t\t\t\t\t<sr7-slide id=\"SR7_1_1-6\" data-key=\"6\">\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-6-9\" class=\"sr7-layer\">TO SERVE<br \/>\nTHE WELLNESS<br \/>\nOF THE PATIENTS<br \/>\n<\/sr7-txt>\n\t\t\t\t\t\t<\/sr7-slide>\n\t\t\t\t\t\t<sr7-slide id=\"SR7_1_1-7\" data-key=\"7\">\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-7-0\" class=\"sr7-layer\">Handling products enquiries from healthcare professionals and patients.<\/sr7-txt>\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-7-9\" class=\"sr7-layer\">MEDICAL<br \/>\nINFORMATION<br \/>\n<\/sr7-txt>\n\t\t\t\t\t\t<\/sr7-slide>\n\t\t\t\t\t\t<sr7-slide id=\"SR7_1_1-8\" data-key=\"8\">\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-8-0\" class=\"sr7-layer\">Turn-key solutions and services for Pharmacovigilance, Materiovigilance, Cosmetovigilance, Nutrivigilance and Toxicovigilance.<\/sr7-txt>\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-8-9\" class=\"sr7-layer\">VIGILANCES<\/sr7-txt>\n\t\t\t\t\t\t<\/sr7-slide>\n\t\t\t\t\t\t<sr7-slide id=\"SR7_1_1-9\" data-key=\"9\">\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-9-0\" class=\"sr7-layer\">Ensure compliance with legislative, regulatory and administrative requirements.<\/sr7-txt>\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-9-9\" class=\"sr7-layer\">COMPLIANCE<\/sr7-txt>\n\t\t\t\t\t\t<\/sr7-slide>\n\t\t\t\t\t\t<sr7-slide id=\"SR7_1_1-23\" data-key=\"23\">\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-23-0\" class=\"sr7-layer\">A full range of regulatory services to support your pharmaceutical products at all stages of their lifecycle in France and internationally.<\/sr7-txt>\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_1_1-23-9\" class=\"sr7-layer\">REGULATORY AFFAIRS<\/sr7-txt>\n\t\t\t\t\t\t<\/sr7-slide>\n\t\t\t\t\t\t<sr7-slide id=\"SR7_1_1-24\" data-key=\"24\">\n\t\t\t\t\t\t<\/sr7-slide>\n\t\t\t\t\t<\/sr7-content>\n\t\t\t\t\t<image_lists style=\"display:none\">\n\t\t\t\t\t\t<img data-src=\"\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/04\/home-header-1@2x-300x300.png\" data-libid=\"1850\" data-lib=\"medialibrary\" title=\"home-header-1@2x\" width=\"0\" height=\"0\" 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].fn();\n\t\t\t\t<\/script>\n<\/div>\n\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-top-section elementor-element elementor-element-1655b6a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1655b6a\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-759421a\" data-id=\"759421a\" 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-35cb4aa elementor-widget elementor-widget-heading\" data-id=\"35cb4aa\" 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\">OUR EXPERTISE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-844f8b8 elementor-widget elementor-widget-text-editor\" data-id=\"844f8b8\" 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=\"p1\">Our expertise covers French, European and international markets, ensuring full compliance and optimum management of your regulatory files.<\/p>\n\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-7e70b59 elementor-widget elementor-widget-text-editor\" data-id=\"7e70b59\" 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 class=\"custom-ul custom-ul-multiline\">\r\n\t<li>Preparation of marketing authorization applications and management of the marketing authorization lifecycle\r\n\t<p>We take charge of the complete preparation of your Marketing Authorization (MA) applications, ensuring their submission and the follow-up of their registration procedures. We also handle the preparation of your dossiers throughout the lifecycle of your marketing authorization applications. Whether for national, European, or international applications, we guarantee a presentation that complies with current regulatory requirements.<\/p>\r\n<\/li>\r\n<li>Publishing\r\n\t<p>Our publishing service includes the compilation, formatting, and electronic submission of your regulatory files.<\/p>\r\n<\/li>\r\n<li>Control of Promotional Items and Validation of Packaging Items\r\n\t<p>Our teams will ensure that promotional elements and\/or packaging items comply with current regulations and guidelines. They will also check that claims made in promotional materials are truthful and supported by scientific evidence or validated data.<\/p>\r\n<\/li>\r\n<li>Regulatory Watch\r\n\t<p>We continuously monitor regulatory changes so that you can anticipate and react quickly to changes impacting your business.<\/p>\r\n<\/li>\r\n<li>Shortage Management Plan\r\n\t<p>We develop and implement your shortage management plans to help you anticipate and manage out-of-stock situations.<\/p>\r\n<\/li>\r\n<li>Procedures to the ANSM\r\n\t<p>We support you in all your dealings with the French National Agency for the Safety of Medicines and Health Products (ANSM). Whether it&#8217;s for import authorization applications, export declarations, marketing declarations, AMM expiry, or annual declarations of the state of establishment, we ensure efficient preparation and rigorous follow-up of your files.<\/p>\r\n<\/li>\r\n<li>LEA and Transparency in Health\r\n\t<p>We can help you manage your declaration of interest and transparency obligations. Our team ensures that your declarations comply with the requirements of the Transparency of Benefits Act (TBA) and other applicable regulations.<\/p>\r\n<\/li>\r\n<\/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-849dc53 elementor-widget elementor-widget-text-editor\" data-id=\"849dc53\" 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>For more information on our regulatory services and discussion of your specific requirements, please contact us. We are here to support you and guarantee a quality service that meets the requirements of the authorities as well as your needs and expectations.<\/p>\n\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-af533ca elementor-align-center elementor-widget elementor-widget-button\" data-id=\"af533ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.universalmedica.com\/en\/contact\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACT US<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>OUR EXPERTISE Our expertise covers French, European and international markets, ensuring full compliance and optimum management of your regulatory files. Preparation of marketing authorization applications and management of the marketing authorization lifecycle We take charge of the complete preparation of your Marketing Authorization (MA) applications, ensuring their submission and the follow-up of their registration procedures. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-5977","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Regulatory affairs - Universal Medica<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.universalmedica.com\/fr\/affaires-reglementaires\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory affairs - Universal Medica\" \/>\n<meta property=\"og:description\" content=\"OUR EXPERTISE Our expertise covers French, European and international markets, ensuring full compliance and optimum management of your regulatory files. 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