{"id":995,"date":"2025-10-21T17:44:30","date_gmt":"2025-10-21T15:44:30","guid":{"rendered":"https:\/\/www.supera-kvaliteta.hr\/medicinal-products\/"},"modified":"2026-09-02T09:19:22","modified_gmt":"2026-09-02T07:19:22","slug":"medicinal-products","status":"publish","type":"page","link":"https:\/\/www.supera-kvaliteta.hr\/en\/medicinal-products\/","title":{"rendered":"Medicinal products"},"content":{"rendered":"<section class=\"l-section wpb_row height_medium width_custom\" style=\"--site-content-width:1050px;\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\"><div class=\"wpb_column vc_column_container us_custom_af7e40fa has_bg_color\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column us_custom_432d3f53 h1-small\"><div class=\"wpb_wrapper\"><h1 style=\"text-align: center;\">Medicinal products<\/h1>\n<div class=\"mod_tquote_quote\">\n<blockquote>\n<p><b>If you can\u2019t describe what you are doing as a process, you don\u2019t know what you\u2019re doing.&#8221;<\/b><span> <\/span>|<span> W. Edwards Deming<br \/><\/span><\/p>\n<\/blockquote>\n<\/div>\n<p>SUPERA KVALITETA provides business consulting services in the field of medicinal products for the implementation, maintenance and improvement of:<\/p>\n<ul>\n<li>Good Manufacturing Practice &#8211; GMP<\/li>\n<li>Good Distribution Practice &#8211; GDP<\/li>\n<li>Good Laboratory Practice &#8211; GLP<\/li>\n<li>Good Clinical Practice -GCP<\/li>\n<li>Good Pharmacovigilance Practice &#8211; GVP<\/li>\n<li>Good Automated Manufacturing Practice &#8211; GAMP<\/li>\n<li>Quality Management System &#8211; QMS<\/li>\n<\/ul>\n<p>Our activities also include project planning and their regular review, support during product development and portfolio management, design for renovated or new facilities (laboratories or pharmaceutical manufacturing facilities), as well as support during the development and validation of computer systems (SDLC), data integrity, and compliance with GAMP. We are able to train staff at all levels of the organization and interact with them, establish and motivate teams to process improvements and lead company-wide programs that result in significant cost reductions. With our help, our clients have successfully implemented and improved their quality system, aligned it with Good Practice Requirements (GxP) and received approvals or certifications from regulatory bodies such as the Ministry of Health of Republic of Croata, US FDA, EU, PIC \/ s and WHO.<\/p>\n<p>We also perform internal audits and third-party audits in compliance with applicable regulatory requirements and standards. We organize and perform <a href=\"https:\/\/www.supera-kvaliteta.hr\/seminari\/\">in-house trainings<\/a> in English language for GxP, risk management, internal audit performing and other topics in the field of medicinal products.<\/p>\n<p>Since 2013, we have been actively supporting a large number of established and newly established pharmaceutical wholesalers in establishing and improving their quality management systems and ensuring compliance with national laws and regulations governing the wholesale distribution of medicinal products, as well as with the EU GDP Guidelines. We have conducted more than 200 seminars covering a wide range of topics related to the wholesale distribution of medicinal products, attended by several thousand participants. We continuously provide training for Responsible Persons (RP) responsible for the wholesale distribution of medicinal products. For more information about our seminars, please see our <a href=\"https:\/\/www.supera-kvaliteta.hr\/seminari\/\">seminar schedule<\/a>.<\/p>\n<p><span>With our support, our clients have successfully implemented and improved their quality management systems, brought them into compliance with Good Practice (GxP) requirements, and obtained approvals or certificates from regulatory authorities such as the Croatian Ministry of Health, the Croatian Agency for Medicinal Products and Medical Devices (HALMED), EU GMP regulatory agencies of EU Member States, pharmaceutical inspectorates in countries across the region, the U.S. FDA, PIC\/S and WHO.<\/span><\/p>\n<p><span>Users of our business consulting services, as well as participants in our pharmaceutical-related seminars, come from Croatia, Slovenia, Bosnia and Herzegovina, Serbia, North Macedonia, Montenegro, Ukraine, the Czech Republic, Switzerland, the United Kingdom, France, Malta, Cyprus, T\u00fcrkiye, India and Cuba.<\/span><\/p>\n<p><span>We conduct internal audits as well as third-party audits in accordance with applicable regulatory requirements and standards.<\/span><\/p>\n<p><span>For companies headquartered outside the EU (companies established in third countries), we offer representation services in the process of obtaining an EU GMP certificate issued by the Croatian Agency for Medicinal Products and Medical Devices (HALMED).<\/span><\/p>\n<p><span>You can learn more about Good Practices and pharmaceutical regulations, internal audits conducting, risk management, and other topics related to the manufacture, quality control, storage and wholesale distribution of medicinal products through our in-house seminars, which can be fully tailored to your specific needs. Information about our open-enrolment seminars can be found in our seminar schedule.<\/span><\/p>\n<\/div><\/div><div class=\"w-gallery fit_cover type_grid action_popup_image ratio_4x3 count_4\" style=\"--columns:4;--items-gap:10px;\"><div class=\"w-gallery-list\"><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"640\" height=\"426\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_headache-1540220_640.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_headache-1540220_640.jpg 640w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_headache-1540220_640-300x200.jpg 300w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"lijekovi_headache-1540220_640\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_headache-1540220_640.jpg\"><\/a><\/div><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"640\" height=\"384\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_tablets-1001224_640.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_tablets-1001224_640.jpg 640w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_tablets-1001224_640-300x180.jpg 300w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"lijekovi_tablets-1001224_640\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_tablets-1001224_640.jpg\"><\/a><\/div><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920-1024x683.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920-1024x683.jpg 1024w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920-300x200.jpg 300w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920.jpg 1920w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"Lijekovi_medicine-1309148_1920\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920.jpg\"><\/a><\/div><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"424\" height=\"283\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_oprema_Fotolia_23974007_XS.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_oprema_Fotolia_23974007_XS.jpg 424w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_oprema_Fotolia_23974007_XS-300x200.jpg 300w\" sizes=\"auto, (max-width: 424px) 100vw, 424px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"manufacturing facility in pharmaceutical factory\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_oprema_Fotolia_23974007_XS.jpg\"><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":992,"parent":0,"menu_order":22,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-995","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - 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