{"id":986,"date":"2022-06-14T10:57:19","date_gmt":"2022-06-14T08:57:19","guid":{"rendered":"https:\/\/www.mbh-law.eu\/life-sciences\/"},"modified":"2023-07-10T13:45:54","modified_gmt":"2023-07-10T11:45:54","slug":"life-sciences","status":"publish","type":"page","link":"https:\/\/www.mbh-law.eu\/en\/life-sciences\/","title":{"rendered":"Life Sciences"},"content":{"rendered":"\n<p class=\"has-text-align-left has-primary-color has-text-color has-medium-font-size\" style=\"font-style:normal;font-weight:500;line-height:2\"><strong>Mixing poison and making a &#8220;medicine&#8221; out of it via the trial-and-error method certainly belongs to the past. Today, the path from the invention to the marketing of a medicinal product or medical device is strictly regulated. We will be of assistance when walking on this not straight road and help you to interpret the road signs correctly.<\/strong><\/p>\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<ul class=\"wp-block-list\"><li><strong>Borderline: medicinal product-medical device-cosmetic-food<\/strong>;<\/li><li><strong>Regulatory consulting in pharmaceutical law and medical device law<\/strong> (Medicines Act (human and veterinary) and Medical Devices Act 2021) as well as in the area of the Medical Devices and In Vitro Diagnostics Regulations and their national implementation;<\/li><li><strong>Legal support for drafting clinical trials (CTRA), NIS and post-marketing surveillance studies (PMS) plus anti-bribery advice<\/strong>;<\/li><li><strong>Assistance with trade registrations under the applicable laws<\/strong> (Trade Act), e.g. wholesale trade permist for pharmaceuticals \/ medical devices, appointment of managing directors under the Trade Act, obtaining operating facility permits;<\/li><li><strong>Obtaining and maintaining GMP\/GCP certificates plus representation before the competent authority<\/strong>;<\/li><li><strong>License agreements:<\/strong> Early development to distribution of approved medicinal productsor CE-certified medical devices\/IVDs (distribution contracts);<\/li><li><strong>Production contracts<\/strong> (special focus on GMP)\/contract manufacturing contracts;<\/li><li><strong>Reimbursement of medicinal products<\/strong> (Reimbursement Codex) and for medical devices;<\/li><li><strong>In-house training on advertising law and competition law issues;<\/strong><\/li><li><strong>Support during inspections by national and by the EU Commission<\/strong> (&#8220;dawn raids&#8221;);<\/li><li><strong>Antitrust advice<\/strong>, in particular on R&amp;D contracts and on horizontal and vertical agreements at all trade levels.<\/li><\/ul>\n\n<p class=\"has-cyan-bluish-gray-color has-text-color has-small-font-size\">Foto: CC0 &#8211; Unbekannt &#8211; Wien Museum 58129\/53<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mixing poison and making a &#8220;medicine&#8221; out of it via the trial-and-error method certainly belongs to the past. Today, the path from the invention to the marketing of a medicinal product or medical device is strictly regulated. We will be of assistance when walking on this not straight road and help you to interpret the [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":967,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-large-feature","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-986","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Life Sciences - MBH law<\/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.mbh-law.eu\/en\/life-sciences\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Life Sciences - MBH law\" \/>\n<meta property=\"og:description\" content=\"Mixing poison and making a &#8220;medicine&#8221; out of it via the trial-and-error method certainly belongs to the past. 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