{"id":7308,"date":"2023-05-23T11:34:52","date_gmt":"2023-05-23T09:34:52","guid":{"rendered":"https:\/\/www.sciencepharma.pl\/?post_type=pharmacovigilance&#038;p=7308"},"modified":"2023-12-19T10:29:15","modified_gmt":"2023-12-19T09:29:15","slug":"obsluga-procesu-rejestracji","status":"publish","type":"pharmacovigilance","link":"https:\/\/www.sciencepharma.com\/pl\/services\/obsluga-procesu-rejestracji\/","title":{"rendered":"Obs\u0142uga procesu rejestracji"},"content":{"rendered":"\n<h1 class=\"wp-block-heading\">Obs\u0142uga procesu rejestracji<\/h1>\n\n\n<p style=\"text-align: justify;\">Posiadamy do\u015bwiadczenie w setkach procedur uzyskiwania pozwolenia na dopuszczenie do obrotu obejmuj\u0105ce procedury: narodowe i europejskie- w tym procedury zdecentralizowane (DCP), wzajemnego uznania (MRP\/RUP) , oraz procedur\u0119 centraln\u0105 (CP). Z przyjemno\u015bci\u0105 wsp\u00f3\u0142pracujemy w tym zakresie z r\u00f3\u017cnymi agencjami rejestracyjnymi w Unii Europejskiej, takimi jak\u00a0 AGES (Austria), BfArM (Niemcy), FAMHP (Belgia), BDA (Bu\u0142garia), AIFA (W\u0142ochy), HoH (Cypr), SUKL (Czechy, S\u0142owacja), OGYEI (W\u0119gry), MMA (Malta), INFARMED (Portugalia), AEMPS (Estonia), URPL (Polska) i inne.<\/p>\n<p style=\"text-align: justify;\">Agencjami spoza Unii Europejskiej, z kt\u00f3rymi wsp\u00f3\u0142pracujemy s\u0105 m.in. MHRA (UK), Health Canada i Swissmedic (Szwajcaria).<\/p>\n<p style=\"text-align: justify;\">Nasze szerokie do\u015bwiadczenie umo\u017cliwia nam wsparcie naszych klient\u00f3w w procedurach uzyskania pozwolenia na dopuszczenie w zakresie:<\/p>\n\n\n<ul class=\"wp-block-list\">\n<li>Opracowania dokumentacji eCTD i sk\u0142adania dossier do urz\u0119d\u00f3w rejestracyjnych<\/li>\n\n\n\n<li>Aktywnego monitorowania procesu rejestracji narodowej i europejskiej<\/li>\n\n\n\n<li>Pe\u0142nego wsparcia podczas kontakt\u00f3w z narodowymi agencjami rejestracyjnymi oraz EMA<\/li>\n\n\n\n<li>Przygotowywania odpowiedzi na uwagi agencji rejestracyjnych<\/li>\n\n\n\n<li>Koordynowania procedur rejestracyjnych jako \u201eCentral Coordinator\u201d lub jako \u201eLocal Point\u201d w procedurach wzajemnego uznania i zdecentralizowanej (MRC i DCP).<\/li>\n\n\n\n<li>Przygotowania <a href=\"https:\/\/www.sciencepharma.com\/pl\/uslugi\/druki-informacyjne\/\" data-type=\"URL\" data-id=\"https:\/\/www.sciencepharma.com\/pl\/uslugi\/druki-informacyjne\/\">Druk\u00f3w Informacyjnych<\/a> wraz z <a href=\"https:\/\/www.sciencepharma.com\/pl\/uslugi\/tlumaczenie-drukow-informacyjnych\/\" data-type=\"URL\" data-id=\"https:\/\/www.sciencepharma.com\/pl\/uslugi\/tlumaczenie-drukow-informacyjnych\/\">t\u0142umaczeniem na j\u0119zyk polski<\/a>.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Obs\u0142uga procesu rejestracji Posiadamy do\u015bwiadczenie w setkach procedur uzyskiwania pozwolenia na dopuszczenie do obrotu obejmuj\u0105ce procedury: narodowe i europejskie- w tym procedury zdecentralizowane (DCP), wzajemnego uznania (MRP\/RUP) , oraz procedur\u0119 centraln\u0105 (CP). Z przyjemno\u015bci\u0105 wsp\u00f3\u0142pracujemy w tym zakresie z r\u00f3\u017cnymi agencjami rejestracyjnymi w Unii Europejskiej, takimi jak\u00a0 AGES (Austria), BfArM (Niemcy), FAMHP (Belgia), BDA (Bu\u0142garia), [&hellip;]<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"inline_featured_image":false},"taxonomy":[83,87],"class_list":["post-7308","pharmacovigilance","type-pharmacovigilance","status-publish","hentry","taxonomy-uslugi-rejestracyjne","taxonomy-proces-rejestracji"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Obs\u0142uga procesu rejestracji - SciencePharma<\/title>\n<meta name=\"description\" content=\"Posiadamy do\u015bwiadczenie w setkach procedur uzyskiwania pozwolenia na dopuszczenie do obrotu obejmuj\u0105ce procedury.\" \/>\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.sciencepharma.com\/pl\/services\/obsluga-procesu-rejestracji\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Obs\u0142uga procesu rejestracji - 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