{"id":4788,"date":"2016-08-10T09:13:51","date_gmt":"2016-08-10T07:13:51","guid":{"rendered":"http:\/\/www.rapharm.eu\/en\/?page_id=4788"},"modified":"2016-08-30T17:53:36","modified_gmt":"2016-08-30T15:53:36","slug":"consulting-services","status":"publish","type":"page","link":"https:\/\/www.rapharm.eu\/en\/consulting-services\/","title":{"rendered":"Consulting &#038; Services"},"content":{"rendered":"<style type=\"text\/css\"> \n#cmsms_row_69eb8c7983f98 .cmsms_row_outer_parent { \n\tpadding-top: 0px; \n} \n\n#cmsms_row_69eb8c7983f98 .cmsms_row_outer_parent { \n\tpadding-bottom: 70px; \n} \n\n \n#cmsms_heading_69eb8c79843e9 { \n\ttext-align:left; \n\tmargin-top:0px; \n\tmargin-bottom:20px; \n} \n\n#cmsms_heading_69eb8c79843e9 .cmsms_heading { \n\ttext-align:left; \n} \n\n#cmsms_heading_69eb8c79843e9 .cmsms_heading, #cmsms_heading_69eb8c79843e9 .cmsms_heading a { \n\tfont-weight:600; \n\tfont-style:normal; \n} \n\n#cmsms_heading_69eb8c79843e9 .cmsms_heading_divider { \n} \n\n \n#cmsms_heading_69eb8c798473d { \n\ttext-align:left; 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\n} \n\n#cmsms_heading_69eb8c7985312 .cmsms_heading, #cmsms_heading_69eb8c7985312 .cmsms_heading a { \n\tfont-weight:600; \n\tfont-style:normal; \n} \n\n#cmsms_heading_69eb8c7985312 .cmsms_heading_divider { \n} \n\n \n#cmsms_heading_69eb8c79853ab { \n\ttext-align:left; \n\tmargin-top:20px; \n\tmargin-bottom:20px; \n} \n\n#cmsms_heading_69eb8c79853ab .cmsms_heading { \n\ttext-align:left; \n} \n\n#cmsms_heading_69eb8c79853ab .cmsms_heading, #cmsms_heading_69eb8c79853ab .cmsms_heading a { \n\tfont-weight:normal; \n\tfont-style:normal; \n} \n\n#cmsms_heading_69eb8c79853ab .cmsms_heading_divider { \n} \n\n #cmsms_icon_list_items_69eb8c79853d9 { \n\tpadding-left:34px; \n} \n\n#cmsms_icon_list_items_69eb8c79853d9 .cmsms_icon_list_item:before { \n\tfont-size:14px; \n\tleft:-34px; \n} \n \n#cmsms_divider_69eb8c7985589 { \n\tborder-bottom-width:0px; \n\tborder-bottom-style:solid; \n\tpadding-top:20px; \n\tmargin-bottom:0px; \n} \n<\/style><div id=\"cmsms_row_69eb8c7983f98\" class=\"cmsms_row cmsms_color_scheme_default\">\n<div class=\"cmsms_row_outer_parent\">\n<div class=\"cmsms_row_outer\">\n<div class=\"cmsms_row_inner\">\n<div class=\"cmsms_row_margin\">\n<div class=\"cmsms_column one_first\">\n\n<div id=\"cmsms_heading_69eb8c79843e9\" class=\"cmsms_heading_wrap cmsms_heading_align_left\">\n\t<h2 class=\"cmsms_heading\">Medicinal products<\/h2>\n<\/div><div class=\"cmsms_text\">\n<p>From assistance in simple regulatory tasks to ensuring full regulatory compliance.<\/p>\n<p>From assistance with performing regulatory activities to outsourcing.\u00a0Outsourcing is a key strategy that enables you to focus on your competitiveness.<\/p>\n<\/div>\n\n<div id=\"cmsms_heading_69eb8c798473d\" class=\"cmsms_heading_wrap cmsms_heading_align_left\">\n\t<h3 class=\"cmsms_heading\">Regulatory support prior to obtaining marketing authorisation<\/h3>\n<\/div> \n<ul id=\"cmsms_icon_list_items_69eb8c798478f\" class=\"cmsms_icon_list_items cmsms_icon_list_type_list cmsms_icon_list_pos_left cmsms_color_type_border\"><li id=\"cmsms_icon_list_item_69eb8c79848d7\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Documentation compliance checks<\/li><li id=\"cmsms_icon_list_item_69eb8c798491a\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Licensing support<\/li><li id=\"cmsms_icon_list_item_69eb8c7984965\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Optimisation of regulatory procedures<\/li><li id=\"cmsms_icon_list_item_69eb8c7984996\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Effective communication with competent authorities and industry<\/li><li id=\"cmsms_icon_list_item_69eb8c79849c0\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Responding to regulatory authorities\u2032 questions<\/li><li id=\"cmsms_icon_list_item_69eb8c79849e7\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Expert opinions, overviews (pre-clinical, clinical) and dossier preparation and submission<\/li><li id=\"cmsms_icon_list_item_69eb8c7984a0b\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Assisting in GMP compliance<\/li><\/ul>\n<div id=\"cmsms_heading_69eb8c7984a4a\" class=\"cmsms_heading_wrap cmsms_heading_align_left\">\n\t<h3 class=\"cmsms_heading\">Life-cycle management regulatory support<\/h3>\n<\/div> \n<ul id=\"cmsms_icon_list_items_69eb8c7984a7b\" class=\"cmsms_icon_list_items cmsms_icon_list_type_list cmsms_icon_list_pos_left cmsms_color_type_border\"><li id=\"cmsms_icon_list_item_69eb8c7984aff\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Regulatory tasks necessary for maintaining marketing authorisations (variations and renewals)<\/li><li id=\"cmsms_icon_list_item_69eb8c7984b2e\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">SmPC\/PIL services (QRD compliance, translations, artwork\u2026)<\/li><li id=\"cmsms_icon_list_item_69eb8c7984b55\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Advertising review and compliance<\/li><li id=\"cmsms_icon_list_item_69eb8c7984b8b\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Pharmacovigilance and safety issues<\/li><\/ul>\n<div id=\"cmsms_divider_69eb8c7984bda\" class=\"cl\"><\/div><div class=\"cmsms_text\">\n<p><a href=\"http:\/\/www.rapharm.eu\/en\/contact\/\">Contact us<\/a> for more information on further services and find out how we can tailor these to you.<\/p>\n<\/div>\n\n<div id=\"cmsms_heading_69eb8c7984c68\" class=\"cmsms_heading_wrap cmsms_heading_align_left\">\n\t<h2 class=\"cmsms_heading\">Medical devices<\/h2>\n<\/div><div class=\"cmsms_text\">\n<p>We offer regulatory assistance to medical devices manufacturers, wholesalers and retailers \/ specialised shops. We can help with complicated regulatory compliance and outsourcing.<\/p>\n<\/div>\n\n<div id=\"cmsms_heading_69eb8c7984cca\" class=\"cmsms_heading_wrap cmsms_heading_align_left\">\n\t<h3 class=\"cmsms_heading\">Professional regulatory support<\/h3>\n<\/div> \n<ul id=\"cmsms_icon_list_items_69eb8c7984cf7\" class=\"cmsms_icon_list_items cmsms_icon_list_type_list cmsms_icon_list_pos_left cmsms_color_type_border\"><li id=\"cmsms_icon_list_item_69eb8c7984d76\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">May be decisive in borderline and classification issues<\/li><li id=\"cmsms_icon_list_item_69eb8c7984da9\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Before acquiring CE mark, helps you get to market faster<\/li><li id=\"cmsms_icon_list_item_69eb8c7984f4c\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">After acquiring CE mark, makes post-marketing surveillance easier, especially vigilance issues<\/li><\/ul>\n<div id=\"cmsms_heading_69eb8c7984fb4\" class=\"cmsms_heading_wrap cmsms_heading_align_left\">\n\t<h3 class=\"cmsms_heading\">Professional regulatory support we provide<\/h3>\n<\/div> \n<ul id=\"cmsms_icon_list_items_69eb8c7984fe3\" class=\"cmsms_icon_list_items cmsms_icon_list_type_list cmsms_icon_list_pos_left cmsms_color_type_border\"><li id=\"cmsms_icon_list_item_69eb8c798506a\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Classification of products as medical devices<\/li><li id=\"cmsms_icon_list_item_69eb8c798509d\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Product description<\/li><li id=\"cmsms_icon_list_item_69eb8c79850cb\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Medical device classification (class I, IIa, IIb, III)<\/li><li id=\"cmsms_icon_list_item_69eb8c79850f6\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Optimal choice of Conformity Assessment Procedure<\/li><li id=\"cmsms_icon_list_item_69eb8c798511f\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Product development<\/li><li id=\"cmsms_icon_list_item_69eb8c7985149\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Compliance with general safety and performance requirements (essential requirements)<\/li><li id=\"cmsms_icon_list_item_69eb8c798516f\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Preparation of technical documentation<\/li><li id=\"cmsms_icon_list_item_69eb8c7985195\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">EC certification procedure and Declaration of Conformity<\/li><li id=\"cmsms_icon_list_item_69eb8c79851bb\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Labelling and Instruction for Use services<\/li><li id=\"cmsms_icon_list_item_69eb8c79851e3\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Risk assessment, risk management<\/li><li id=\"cmsms_icon_list_item_69eb8c798520c\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Vigilance and safety issues<\/li><li id=\"cmsms_icon_list_item_69eb8c7985234\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Registration support (activity, medical devices) with competent authority<\/li><\/ul>\n<div id=\"cmsms_divider_69eb8c798526d\" class=\"cl\"><\/div><div class=\"cmsms_text\">\n<p>We will help you develop standard operating procedures (SOPs) linked to your activities: including post-marketing surveillance, development and maintenance of vigilance systems for medical devices.<\/p>\n<p><a href=\"http:\/\/www.rapharm.eu\/en\/contact\/\">Contact us<\/a> for more information on further services and find out how we can tailor these to you.<\/p>\n<\/div>\n\n<div id=\"cmsms_heading_69eb8c7985312\" class=\"cmsms_heading_wrap cmsms_heading_align_left\">\n\t<h2 class=\"cmsms_heading\">Food supplements<\/h2>\n<\/div><div class=\"cmsms_text\">\n<p>Assisting you in achieving regulatory excellence in the food supplement sector.<\/p>\n<p>We offer regulatory assistance to food supplement manufacturers, importers and wholesalers. Let us assist you with all the complicated regulatory compliance and outsourcing.<\/p>\n<\/div>\n\n<div id=\"cmsms_heading_69eb8c79853ab\" class=\"cmsms_heading_wrap cmsms_heading_align_left\">\n\t<h3 class=\"cmsms_heading\">Professional regulatory support we provide<\/h3>\n<\/div> \n<ul id=\"cmsms_icon_list_items_69eb8c79853d9\" class=\"cmsms_icon_list_items cmsms_icon_list_type_list cmsms_icon_list_pos_left cmsms_color_type_border\"><li id=\"cmsms_icon_list_item_69eb8c7985452\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Classification of products as food supplements<\/li><li id=\"cmsms_icon_list_item_69eb8c7985487\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Compliance and composition review before marketing in Slovenia<\/li><li id=\"cmsms_icon_list_item_69eb8c79854b4\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Regulatory compliance<\/li><li id=\"cmsms_icon_list_item_69eb8c79854dc\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Labelling compliance review and preparation<\/li><li id=\"cmsms_icon_list_item_69eb8c7985504\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Nutrition and health claims reviews<\/li><li id=\"cmsms_icon_list_item_69eb8c798552f\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Compliance with Good Hygiene Practices and general requirements for food premises, education, traceability, recall etc.<\/li><li id=\"cmsms_icon_list_item_69eb8c7985557\" class=\"cmsms_icon_list_item cmsms-icon-ok-2\">Inspection assistance<\/li><\/ul>\n<div id=\"cmsms_divider_69eb8c7985589\" class=\"cl\"><\/div><div class=\"cmsms_text\">\n<p><a href=\"http:\/\/www.rapharm.eu\/en\/contact\/\">Contact us<\/a> for more information on our services and find out how we can make these work for you.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4788","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Consulting &amp; 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