{"id":8,"date":"2018-11-26T12:46:25","date_gmt":"2018-11-26T12:46:25","guid":{"rendered":"https:\/\/www.hcsth.com\/services\/"},"modified":"2021-06-15T12:06:59","modified_gmt":"2021-06-15T10:06:59","slug":"companies-idea-regulatory","status":"publish","type":"page","link":"https:\/\/www.hcsth.com\/de\/companies-idea-regulatory\/","title":{"rendered":"companies idea regulatory"},"content":{"rendered":"\"idea\"\n

Innovative regulatory affairs strategies for innovative products – EU\/UK legal representative services<\/p>\n

IDEA Regulatory unterst\u00fctzt Pharma-, Biotechnologie- und Medizintechnikunternehmen beim Zugang zu den europ\u00e4ischen M\u00e4rkten. Mit Niederlassungen in London, Dublin und M\u00fcnchen steht IDEA Regulatory den Unternehmen als Ressource zur Verf\u00fcgung, um ihnen zu helfen, die Zulassungswege in der EU und im Vereinigten K\u00f6nigreich zu verstehen und zu beschreiten und die Bewertungen zu beschleunigen, insbesondere f\u00fcr sogenannte Orphan-Indikationen, ein Bereich, auf den das Unternehmen spezialisiert ist. Der Prozess der Einstufung eines Produkts als Arzneimittel f\u00fcr seltene Leiden, die Festlegung der notwendigen Voraussetzungen f\u00fcr die Einleitung des Zulassungsverfahrens und die Vorbereitung der klinischen Versuche und der Einreichung der Unterlagen ist ein wesentlicher Bestandteil von IDEA Regulatory. Dar\u00fcber hinaus kann IDEA Regulatory als Vertreter eines Unternehmens in Europa und im Vereinigten K\u00f6nigreich auftreten. IDEA Regulatory bietet professionelle Beratung und Unterst\u00fctzung bei allen Fragen, die ein Unternehmen in Bezug auf die Zulassungsverfahren bei der EMA und der MHRA haben k\u00f6nnte, und verf\u00fcgt \u00fcber Partner in den USA f\u00fcr alle FDA-Angelegenheiten.<\/p>\n

\n\t\tFrequently Asked Questions\n\t<\/h2>\n\t\t\t\t\t\t

Wie kann IDEA mein Produkt in Europa unterst\u00fctzen?<\/h4>\n\t\t\t

IDEA Regulatory kennt die Bed\u00fcrfnisse von Unternehmen des Gesundheitswesens, die nicht im Vereinigten K\u00f6nigreich oder in der EU ans\u00e4ssig sind und klinische Forschung in diesen Gebieten durchf\u00fchren m\u00f6chten. IDEA Regulatory f\u00fchrt seit vielen Jahren klinische Studien als gesetzlicher Vertreter in der EU und im Vereinigten K\u00f6nigreich durch und begleitet Produkte von den fr\u00fchen Phasen bis zur endg\u00fcltigen Marktzulassung.<\/p>\n\t\t\t\t\t\t

Wie kann IDEA Regulatory mein \"Orphan Drug\" unterst\u00fctzen?<\/h4>\n\t\t\t

IDEA Regulatory kann Ihren Antrag auf Ausweisung als Orphan Drug unterst\u00fctzen, einschlie\u00dflich gemeinsamer Verfahren von FDA und EMA. Dies erm\u00f6glicht Ihrem Unternehmen die Fortsetzung der klinischen Entwicklung in vielen L\u00e4ndern mit gemeinsamer regulatorischer Unterst\u00fctzung.<\/p>\n\t\t\t\t\t\t

Wie kann ich mein Medizinprodukt im Vereinigten K\u00f6nigreich oder in der EU registrieren lassen?<\/h4>\n\t\t\t

IDEA Regulatory has been guiding companies with CE mark registration procedures for many years and now – following Brexit – continues to support the neccessary procedures and performance of trials under the new EU legislation.<\/p>\n\t\t\t\n\t\t\t\t\t\t\tWEITER ZU IDEA REGULATORY\n\t\t\t\t\t<\/a>","protected":false},"excerpt":{"rendered":"

Innovative regulatory affairs strategies for innovative products – EU\/UK legal representative services IDEA Regulatory is devoted to supporting pharmaceutical, biotechnology and medical device companies when accessing European markets. With offices in London, Dublin and Munich, IDEA Regulatory is a resource available to companies to assist them in understanding and accessing the regulatory submission paths in […]<\/p>","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-8","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/pages\/8","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/comments?post=8"}],"version-history":[{"count":35,"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/pages\/8\/revisions"}],"predecessor-version":[{"id":3291,"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/pages\/8\/revisions\/3291"}],"wp:attachment":[{"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/media?parent=8"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}