{"id":22733,"date":"2020-11-16T10:08:30","date_gmt":"2020-11-16T09:08:30","guid":{"rendered":"https:\/\/kymos.com\/news\/proves-i-llancament-per-lots-la-vida-despres-del-brexit\/"},"modified":"2025-08-07T09:43:22","modified_gmt":"2025-08-07T07:43:22","slug":"proves-i-llancament-per-lots-la-vida-despres-del-brexit","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/proves-i-llancament-per-lots-la-vida-despres-del-brexit\/","title":{"rendered":"Proves i llan\u00e7ament per lots: la vida despr\u00e9s del Brexit"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\">We at<a href=\"https:\/\/kymos.com\/ca\/kymos\/\" data-wpel-link=\"internal\"> KYMOS<\/a> and <a href=\"https:\/\/www.asphalion.com\/\" data-wpel-link=\"external\">ASPHALION<\/a> are long-time partners in providing analytical and regulatory services to international pharma and biotech sectors. Our testimony goes beyond the conventional <em>\u201cCRO trading with UK clients\u201d<\/em> to overcome internalization barriers. Our respective services are part of a complex international supply chain that makes the effects of Brexit more visible and quantifiable. Quality Control (QC) is one of the most interdisciplinary departments at KYMOS with high demand from international clients, particularly for EU Batch Testing and Release for drug products and IMPs. The intrinsic characteristics of these services make them a great non-tariff indicator of the current mood of the market.<\/span><\/p>\n<div class=\"blog-content\">\n<div class=\"field field-name-body field-type-text-with-summary field-label-hidden\">\n<div class=\"field-items\">\n<div class=\"field-item even\">\n<p><span style=\"font-size: 14pt;\">Brexit embarked on some important changes to the approval of drug products in the UK, where immediately following 31 January (Brexit day), they went into a <strong><a href=\"https:\/\/www.bbc.co.uk\/news\/uk-politics-50838994\" data-wpel-link=\"external\">transition period<\/a><\/strong> with the EU to give both sides breathing room to agree on the new arrangements. This transition period will last until 31 December <u>2020<\/u>, when the new EU-UK relationship will begin as the deadline for extending the transition has now passed. Starting on 1st January <u>2021<\/u>, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK\u2019s standalone medicines and medical devices regulator and act as the sole barrier to apply in clinical trials, import and export, licensing and other activities.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">When working with batch releases, it is crucial to have a well-established transfer of methods as delays can compromise the stock of pharmaceutical products around the world. Llu\u00eds Racionero, Director of QC, worked in the Dev\/Val department at KYMOS before leading up the QC department, so his expertise spans every step of the process, from developing methods to validation, transfer and sample analysis. The demand for Batch Testing and Release (T&amp;R) services has experienced a 5-fold increase during the last couple of years, possibly due to a lack of trust in the UK Government mitigating measures post-Brexit.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Moreover, most of KYMOS\u2019 UK Batch T&amp;R clients manufacture their Drug Products (DPs) outside of the UK, therefore, they may seek to ensure project continuity and to minimize risks through CROs and Quality Persons (QPs) based in continental Europe. In addition, KYMOS has not actively promoted their Batch T&amp;R services indicating that the rise in demand is inbound and unprompted and likely attributed to the new regulatory requirements between the UK and EU post-Brexit.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">KYMOS is a GMP and GLP-certified CRO inspected regularly by EMA and FDA. Clients working with KYMOS can have peace of mind they have a partner for every step of the process in a range of product forms from powders to injectable solutions analyses using a broad range of techniques. The high-quality standards of KYMOS are applied to every project with continuous improvement in data integration and compilation. Our clients know that they can trust not only the quality of our work but in our flexibility. When an urgent matter comes up, we do our best to adapt to our client&#8217;s needs.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Our partners at ASPHALION help out through their extensive experience in regulatory consultancy. They believe that Brexit will cause UK manufacturing, QPs and batch release activities to move into continental Europe to ensure EU approval after the transition period. This year, ASPHALION has supported several pharmaceutical companies to adapt their infrastructure\/procedures according to the new expected legislations, defined by MHRA guidelines published on September the 1st, 2020 on how to act from the 1st of January, 2021 for the marketing of medicinal products in the United Kingdom. Some uncertainty still exists within these guidelines, nevertheless, during the transition period, ASPHALION recommends strongly following MHRA recommendations and employing the opinion of regulatory affairs consultants in both the UK and the EU. As a result, ASPHALION opened a new office in the city centre of London in 2020 to provide services to customers with ongoing or planned operations in the United Kingdom, one of Europe\u2019s most important markets. The London office is the most recent addition to a growing list of established ASPHALION locations that now include Spain, Germany and the Netherlands.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">If the assumptions regarding current trends outside the UK are correct, the increase in batch testing and release activities should persist during the 2020 transition, and beyond. Firms that went through the hassle of shifting to a continental CRO, including method transfer and validation as well as provider selection, may demand significant guarantees to shift back. The tandem KYMOS-ASPHALION can provide clients with robust regulatory consultancy services and the highest quality Batch Testing and Release services.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><em>ASPHALION can support with in Regulatory aspects affecting Brexit offering services as acting as your UK-based MAH and UK-local contact with MHRA. ASPHALION also offers services such as Re-establish your SME status; UK PIP and YK Orphan designation, Responsible Person for Import (RP-I), Pharmacovigilance: Act as your UK-QPPV and eSubmission: Publishing &amp; submission thought UK portal, baselines for grandfathered centralized products. For more information contact <a href=\"mailto:info@asphalion.com\" data-wpel-link=\"internal\">info@asphalion.com<\/a>.<\/em><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":14959,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[],"class_list":["post-22733","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Proves i llan\u00e7ament per lots: la vida despr\u00e9s del Brexit - Kymos<\/title>\n<meta name=\"description\" content=\"Proves i alliberament de lots: la vida despr\u00e9s del Brexit - Kymos \u00e9s un importador i fabricant certificat (titular de MIA). 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Experience Joan Puig de Dou started his career at Laboratorios Menarini first as scientist later as Qualified Person and finally as Operations General Manager. 2010 he entered Kymos where he became CEO in 2015. 2022 Joan Puig de Dou was elected as president of CataloniaBio&amp;HealthTech to represent the Catalonian biotech industry nationally and internationally. Expertise Joan Puig de Dou has extensive experience in writing scientific content adopting a didactic approach that fits any reader\u2019s level of expertise. He publishes regularely on Kymos\u2019 webpage, social media and in the specialized press. Education He graduated from Universitat de Barcelona as Pharmacist and from IESE Business School\u2019s Programa Diecci\u00f3n General (PDG) Want to know him better? Read his interview in PharmaBoardrooom in January 2019 and more about his presidency of CataloniaBio at Parc Sc\u00edentific de Barcelona.","url":"https:\/\/kymos.com\/ca\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts\/22733","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/comments?post=22733"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts\/22733\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/media\/14959"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/media?parent=22733"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/categories?post=22733"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/tags?post=22733"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}