{"id":357,"date":"2021-01-06T06:55:31","date_gmt":"2021-01-06T06:55:31","guid":{"rendered":"https:\/\/kbmpharma.eu\/company\/"},"modified":"2022-11-09T10:56:48","modified_gmt":"2022-11-09T10:56:48","slug":"ravimite-registreerimine-raviminfo-ravimite-muugiluba-ravimiohutus-meditsiinitolge-konsultatsioonifirma","status":"publish","type":"page","link":"https:\/\/kbmpharma.eu\/en\/ravimite-registreerimine-raviminfo-ravimite-muugiluba-ravimiohutus-meditsiinitolge-konsultatsioonifirma\/","title":{"rendered":"Regulatory Affairs and Pharmacovigilance"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"357\" class=\"elementor elementor-357\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7ee3535 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"7ee3535\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a7bd651\" data-id=\"a7bd651\" data-element_type=\"column\" data-e-type=\"column\">\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-top-section elementor-element elementor-element-0744403 elementor-section-content-middle main-section elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0744403\" 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-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-aa5fc99\" data-id=\"aa5fc99\" 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-179ebbb elementor-widget elementor-widget-heading\" data-id=\"179ebbb\" 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 and Pharmacovigilance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-70be55b elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"70be55b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78ecc39 break-this-text elementor-widget elementor-widget-text-editor\" data-id=\"78ecc39\" 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>KBM Pharma provides consultation services and support for pharmaceutical industry.<br><br><b>Regulatory Affairs<\/b><\/p><p><strong><b>Regulatory Applications and Maintenance:<\/b><\/strong><\/p><ul><li>Preparation and submission of applications for Marketing Authorisation, Renewal and Variation to the Estonian State Agency of Medicines, communication between the State Agency of Medicines and the Applicant<\/li><li>Representing the Marketing Authorisation Holder at national level<\/li><li>Consulting the Marketing Authorisation Holder regarding local legislation and requirements<\/li><\/ul><p><strong><b>Translation and Quality check of Product Information, other medical materials and artworks<\/b><\/strong><\/p><ul><li>Preparation\/translation\/update of Estonian Product Information and other medical materials, quality control of medical translations<\/li><li>Review of artworks of product information and Additional risk minimisation materials<\/li><\/ul><p><strong><b>Pharmacovigilance support on national level<\/b><\/strong><\/p><ul><li class=\"translation-block\">Collecting, translating and reporting pharmacovigilance related information (adverse reactions, quality complaints and other special reportable situations), Pharmacovigilance follow-up<\/li><li>Preparation, update and submission of Additional risk minimisation measures<\/li><li>Literature search (monitoring medical journals), translation of articles<\/li><\/ul><p><strong><b>Support on placing following products on the market: food supplements, medical devices, biocides, food for special medicinal purposes<\/b><\/strong><\/p><ul><li>Consulting the Manufacturer or Distributor regarding local legislation and requirements<\/li><li>Classification of products<\/li><li>Translation of labeling and product information and check of artworks<\/li><li>Registration and notification of Authorities about placing products on the market<\/li><\/ul><p><strong><b>Review of promotional materials and consulting on local requirements<\/b><\/strong><\/p><p><strong><b>Preparation of applications for reimbursement<\/b><\/strong><\/p><p>We tailor our services to meet your specific needs and budget.<\/p><p>*We also offer the opportunity for short-term projects (e.g. replacing MAH\u00b4s employee during vacation).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Ravimite registreerimine ja ravimiohutus KBM Pharma pakub ravimifirmadele konsultatsiooni ja tuge. Ravimite registreerimine: Ravimite m\u00fc\u00fcgiloa taotluste, m\u00fc\u00fcgiloa uuendamise ja muutuse taotluste ettevalmistamine ja esitamine Ravimiametile, protseduuriga seotud kommunikatsioon Ravimiameti ja m\u00fc\u00fcgiloa hoidja vahel M\u00fc\u00fcgiloa hoidja esindamine kohalikul tasandil M\u00fc\u00fcgiloa hoidja n\u00f5ustamine seadusandluse ja kohalike n\u00f5uete osas Ravimiteabe t\u00f5lkimine, t\u00f5lgete ja kavandite kontroll: Eestikeelse ravimiteabe ja [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":960,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-357","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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