{"id":1322,"date":"2019-01-14T16:18:08","date_gmt":"2019-01-14T16:18:08","guid":{"rendered":"https:\/\/m-vm.de\/leistungen\/"},"modified":"2020-03-13T19:40:56","modified_gmt":"2020-03-13T18:40:56","slug":"services","status":"publish","type":"page","link":"https:\/\/m-vm.de\/en\/services\/","title":{"rendered":"Services"},"content":{"rendered":"<p><div id=\"fusion-scroll-section-1\" class=\"fusion-scroll-section\" data-section=\"1\" ><div id=\"qualitymanagement\" class=\"fusion-scroll-section-element active\" data-section=\"1\" data-element=\"1\" style=\"transition-duration:450ms;&quot;\" ><div id=\"qualitymanagement\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 nonhundred-percent-fullwidth hundred-percent-height hundred-percent-height-center-content hundred-percent-height-scrolling fusion-equal-height-columns\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#ecefef;border-style:solid;\" id=\"qualitymanagement\" ><div class=\"fusion-fullwidth-center-content\"><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_2 1_2 fusion-one-half fusion-column-first fusion-animated\" style=\"width:50%;width:calc(50% - ( ( 10% ) * 0.5 ) );margin-right: 10%;margin-top:25px;margin-bottom:25px;\" data-animationType=\"fadeInRight\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-fa-align-left\"><i class=\"fb-icon-element-1 fb-icon-element fontawesome-icon fa-award fas circle-yes\" style=\"font-size:31.68px;line-height:61.36px;height:63.36px;width:63.36px;border-width:1px;margin-right:18px;\"><\/i><\/div><style>i.fb-icon-element.fontawesome-icon.fb-icon-element-1{ color: #ffffff; background-color: #fc9b01; border-color: rgba(255,255,255,0);}i.fb-icon-element.fontawesome-icon.fb-icon-element-1:hover { color: #ffffff; background-color: #fc9b01; border-color: rgba(255,255,255,0);}<\/style><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-bottom:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><style type=\"text\/css\"><\/style><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"font-size:26px;margin-top:20px;margin-right:0px;margin-bottom:15px;margin-left:0px;\"><h2 class=\"title-heading-left\" style=\"margin:0;font-size:1em;\"><p class=\"content-box-heading\" data-inline-fontsize=\"true\" data-inline-lineheight=\"true\" data-fontsize=\"24\" data-lineheight=\"29\">Quality management<\/p><\/h2><\/div><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 24px; line-height: 1.6em; letter-spacing: -1px;\">More than 20 years of experience in quality management in the pharmaceutical and medical device industry.<\/span><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:15px;margin-bottom:40px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"border-color:#ecefef;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><ul class=\"fusion-checklist fusion-checklist-1\" style=\"font-size:16px;line-height:27.2px;\"><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Introduction \/ development of QM system according to ISO 13485, ISO 9001 and FDA 21 CFR Part 820, EU-GMP guideline, FDA 21 CFR 210 &amp; 211, 21 CFR 11.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Responsible preparation and monitoring of audits by national and international drug authorities (e.g. FDA, ANVISA), notified bodies (e.g. TGA) and customers.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>External QMB\/Interims QMB, also for outsourced sub-processes such as management evaluation, risk management, complaint management, internal and external audits, change control or CAPA management to relieve the quality manager of his work.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Maintenance of QM manual and complete documentation of the QM system.<\/p>\n<\/div><\/li><\/ul><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_2 1_2 fusion-one-half fusion-column-last fusion-animated\" style=\"width:50%;width:calc(50% - ( ( 10% ) * 0.5 ) );margin-top:25px;margin-bottom:25px;\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"552\" height=\"442\" alt=\"Quality management\" title=\"Quality management\" src=\"https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/qualit\u00e4tsmanagement.jpg\" class=\"img-responsive wp-image-1281\" srcset=\"https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/qualit\u00e4tsmanagement-200x160.jpg 200w, https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/qualit\u00e4tsmanagement-400x320.jpg 400w, https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/qualit\u00e4tsmanagement.jpg 552w\" sizes=\"(max-width: 1000px) 100vw, 552px\" \/><\/span><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:15px;margin-bottom:40px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><ul class=\"fusion-checklist fusion-checklist-2\" style=\"font-size:16px;line-height:27.2px;\"><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 MDR.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Selection and monitoring of external suppliers and contract manufacturers.<\/p>\n<\/div><\/li><\/ul><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-scroll-section-element\" data-section=\"1\" data-element=\"2\" style=\"transition-duration:450ms;&quot;\" ><div id=\"development\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 development nonhundred-percent-fullwidth hundred-percent-height hundred-percent-height-center-content hundred-percent-height-scrolling fusion-equal-height-columns\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#ecefef;border-style:solid;\" ><div class=\"fusion-fullwidth-center-content\"><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_2 1_2 fusion-one-half fusion-column-first fusion-animated\" style=\"width:50%;width:calc(50% - ( ( 10% ) * 0.5 ) );margin-right: 10%;margin-top:25px;margin-bottom:25px;\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-fa-align-left\"><i class=\"fb-icon-element-2 fb-icon-element fontawesome-icon fa-microscope fas circle-yes\" style=\"font-size:31.68px;line-height:61.36px;height:63.36px;width:63.36px;border-width:1px;margin-right:18px;\"><\/i><\/div><style>i.fb-icon-element.fontawesome-icon.fb-icon-element-2{ color: #ffffff; background-color: #fc9b01; border-color: rgba(255,255,255,0);}i.fb-icon-element.fontawesome-icon.fb-icon-element-2:hover { color: #ffffff; background-color: #fc9b01; border-color: rgba(255,255,255,0);}<\/style><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-bottom:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><style type=\"text\/css\"><\/style><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"font-size:26px;margin-top:20px;margin-right:0px;margin-bottom:15px;margin-left:0px;\"><h2 class=\"title-heading-left\" style=\"margin:0;font-size:1em;\"><p class=\"content-box-heading\" data-inline-fontsize=\"true\" data-inline-lineheight=\"true\" data-fontsize=\"24\" data-lineheight=\"29\">Development<\/p><\/h2><\/div><div class=\"fusion-text fusion-text-2\"><p><span style=\"font-size: 24px; line-height: 1.6em; letter-spacing: -1px;\">More than 20 years of experience in quality management and development of sterile drugs.<\/span><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:15px;margin-bottom:40px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"border-color:#ecefef;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><ul class=\"fusion-checklist fusion-checklist-3\" style=\"font-size:16px;line-height:27.2px;\"><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Pharmaceutical and medical technology production transfer.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Formulation development, stability testing, optimization of production parameters.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Development of production processes, in particular for the manufacture of sterile products.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Product, process and recipe inventions and their patent applications.<\/p>\n<\/div><\/li><\/ul><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_2 1_2 fusion-one-half fusion-column-last fusion-animated\" style=\"width:50%;width:calc(50% - ( ( 10% ) * 0.5 ) );margin-top:25px;margin-bottom:25px;\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-2 hover-type-none\"><img decoding=\"async\" width=\"552\" height=\"502\" alt=\"Development\" title=\"Development\" src=\"https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/entwicklung.jpg\" class=\"img-responsive wp-image-1283\" srcset=\"https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/entwicklung-200x182.jpg 200w, https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/entwicklung-400x364.jpg 400w, https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/entwicklung.jpg 552w\" sizes=\"(max-width: 1000px) 100vw, 552px\" \/><\/span><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div id=\"qualification\" class=\"fusion-scroll-section-element\" data-section=\"1\" data-element=\"3\" style=\"transition-duration:450ms;&quot;\" ><div id=\"qualification\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 nonhundred-percent-fullwidth hundred-percent-height hundred-percent-height-center-content hundred-percent-height-scrolling fusion-equal-height-columns\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#ecefef;border-style:solid;\" id=\"qualification\" ><div class=\"fusion-fullwidth-center-content\"><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_2 1_2 fusion-one-half fusion-column-first fusion-animated\" style=\"width:50%;width:calc(50% - ( ( 10% ) * 0.5 ) );margin-right: 10%;margin-top:25px;margin-bottom:25px;\" data-animationType=\"fadeInRight\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-fa-align-left\"><i class=\"fb-icon-element-3 fb-icon-element fontawesome-icon fa-folder-plus fas circle-yes\" style=\"font-size:31.68px;line-height:61.36px;height:63.36px;width:63.36px;border-width:1px;margin-right:18px;\"><\/i><\/div><style>i.fb-icon-element.fontawesome-icon.fb-icon-element-3{ color: #ffffff; background-color: #fc9b01; border-color: rgba(255,255,255,0);}i.fb-icon-element.fontawesome-icon.fb-icon-element-3:hover { color: #ffffff; background-color: #fc9b01; border-color: rgba(255,255,255,0);}<\/style><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-bottom:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><style type=\"text\/css\"><\/style><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"font-size:26px;margin-top:20px;margin-right:0px;margin-bottom:15px;margin-left:0px;\"><h2 class=\"title-heading-left\" style=\"margin:0;font-size:1em;\"><p class=\"content-box-heading\" data-inline-fontsize=\"true\" data-inline-lineheight=\"true\" data-fontsize=\"24\" data-lineheight=\"29\">Qualification<\/p><\/h2><\/div><div class=\"fusion-text fusion-text-3\"><p><span style=\"font-size: 24px; line-height: 1.6em; letter-spacing: -1px;\">Over 12 years of experience as Head of Validation and Qualification.<\/span><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:15px;margin-bottom:40px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"border-color:#ecefef;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><ul class=\"fusion-checklist fusion-checklist-4\" style=\"font-size:16px;line-height:27.2px;\"><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Qualification (URS, DQ, IQ, OQ, PQ\/PPQ) of clean rooms, production equipment and analytical equipment.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Validation of production processes.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Validation of cleaning procedures.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Validation of analytical methods.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Validation of computer-aided systems.<\/p>\n<\/div><\/li><\/ul><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_2 1_2 fusion-one-half fusion-column-last fusion-animated\" style=\"width:50%;width:calc(50% - ( ( 10% ) * 0.5 ) );margin-top:25px;margin-bottom:25px;\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-3 hover-type-none\"><img decoding=\"async\" width=\"552\" height=\"502\" alt=\"Qualification\" title=\"Qualification\" src=\"https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/qualifizierung.jpg\" class=\"img-responsive wp-image-1285\" srcset=\"https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/qualifizierung-200x182.jpg 200w, https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/qualifizierung-400x364.jpg 400w, https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/qualifizierung.jpg 552w\" sizes=\"(max-width: 1000px) 100vw, 552px\" \/><\/span><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div id=\"regulatory\" class=\"fusion-scroll-section-element\" data-section=\"1\" data-element=\"4\" style=\"transition-duration:450ms;&quot;\" ><div id=\"regulatory\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-4 nonhundred-percent-fullwidth hundred-percent-height hundred-percent-height-center-content hundred-percent-height-scrolling fusion-equal-height-columns\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#ecefef;border-style:solid;\" id=\"regulatory\" ><div class=\"fusion-fullwidth-center-content\"><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_2 1_2 fusion-one-half fusion-column-first fusion-animated\" style=\"width:50%;width:calc(50% - ( ( 10% ) * 0.5 ) );margin-right: 10%;margin-top:25px;margin-bottom:25px;\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-fa-align-left\"><i class=\"fb-icon-element-4 fb-icon-element fontawesome-icon fa-clipboard-check fas circle-yes\" style=\"font-size:31.68px;line-height:61.36px;height:63.36px;width:63.36px;border-width:1px;margin-right:18px;\"><\/i><\/div><style>i.fb-icon-element.fontawesome-icon.fb-icon-element-4{ color: #ffffff; background-color: #fc9b01; border-color: rgba(255,255,255,0);}i.fb-icon-element.fontawesome-icon.fb-icon-element-4:hover { color: #ffffff; background-color: #fc9b01; border-color: rgba(255,255,255,0);}<\/style><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-bottom:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><style type=\"text\/css\"><\/style><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"font-size:26px;margin-top:20px;margin-right:0px;margin-bottom:15px;margin-left:0px;\"><h2 class=\"title-heading-left\" style=\"margin:0;font-size:1em;\"><p class=\"content-box-heading\" data-inline-fontsize=\"true\" data-inline-lineheight=\"true\" data-fontsize=\"24\" data-lineheight=\"29\">Regulatory Affairs<\/p><\/h2><\/div><div class=\"fusion-text fusion-text-4\"><p><span style=\"font-size: 24px; line-height: 1.6em; letter-spacing: -1px;\">Profound knowledge of European and international GMP regulations and ISO standards.<\/span><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:15px;margin-bottom:40px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"border-color:#ecefef;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><ul class=\"fusion-checklist fusion-checklist-5\" style=\"font-size:16px;line-height:27.2px;\"><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Provision of non-clinical marketing authorisation documentation (CMC part) for medicinal products.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>Preparation of the entire technical documentation for medical devices of all classes.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\"><span style=\"height:27.2px;width:27.2px;margin-right:11.2px;\" class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-circle fas\" style=\"color:#fc9b01;\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\" style=\"margin-left:38.4px;\">\n<p>GAP analyses to assess regulatory compliance.<\/p>\n<\/div><\/li><\/ul><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_2 1_2 fusion-one-half fusion-column-last fusion-animated\" style=\"width:50%;width:calc(50% - ( ( 10% ) * 0.5 ) );margin-top:25px;margin-bottom:25px;\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.8\" data-animationOffset=\"100%\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-4 hover-type-none\"><img decoding=\"async\" width=\"552\" height=\"502\" alt=\"Regulatory Affairs\" title=\"Regulatory Affairs\" src=\"https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/regulatory-affairs.jpg\" class=\"img-responsive wp-image-1287\" srcset=\"https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/regulatory-affairs-200x182.jpg 200w, https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/regulatory-affairs-400x364.jpg 400w, https:\/\/m-vm.de\/wp-content\/uploads\/2019\/03\/regulatory-affairs.jpg 552w\" sizes=\"(max-width: 1000px) 100vw, 552px\" \/><\/span><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><nav id=\"fusion-scroll-section-nav-1\" class=\"fusion-scroll-section-nav scroll-navigation-right\" data-section=\"1\" ><ul><li><a href=\"#fusion-scroll-section-element-1-1\" class=\"fusion-scroll-section-link\" data-name=\"Quality management\" data-element=\"1\"><span class=\"fusion-scroll-section-link-bullet\"><\/span><\/a><\/li><li><a href=\"#fusion-scroll-section-element-1-2\" class=\"fusion-scroll-section-link\" data-name=\"Development\" data-element=\"2\"><span class=\"fusion-scroll-section-link-bullet\"><\/span><\/a><\/li><li><a href=\"#fusion-scroll-section-element-1-3\" class=\"fusion-scroll-section-link\" data-name=\"Qualification\" data-element=\"3\"><span class=\"fusion-scroll-section-link-bullet\"><\/span><\/a><\/li><li><a href=\"#fusion-scroll-section-element-1-4\" class=\"fusion-scroll-section-link\" data-name=\"Regulatory Affairs\" data-element=\"4\"><span class=\"fusion-scroll-section-link-bullet\"><\/span><\/a><\/li><\/ul><\/nav><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"Healthcare Consultant Dr. Andreas B. Meier - Services","_seopress_titles_desc":"I offer you support in quality management, development, qualification and regulatory affairs. Benefit from over 20 years of experience.","_seopress_robots_index":"","footnotes":""},"class_list":["post-1322","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/m-vm.de\/en\/wp-json\/wp\/v2\/pages\/1322","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/m-vm.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/m-vm.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/m-vm.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/m-vm.de\/en\/wp-json\/wp\/v2\/comments?post=1322"}],"version-history":[{"count":6,"href":"https:\/\/m-vm.de\/en\/wp-json\/wp\/v2\/pages\/1322\/revisions"}],"predecessor-version":[{"id":1534,"href":"https:\/\/m-vm.de\/en\/wp-json\/wp\/v2\/pages\/1322\/revisions\/1534"}],"wp:attachment":[{"href":"https:\/\/m-vm.de\/en\/wp-json\/wp\/v2\/media?parent=1322"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}