{"id":41338,"date":"2016-08-30T19:40:03","date_gmt":"2016-08-30T23:40:03","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-drugs\/"},"modified":"2021-02-16T09:13:08","modified_gmt":"2021-02-16T14:13:08","slug":"fda-drugs","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/it\/fda-drugs\/","title":{"rendered":"Farmaci"},"content":{"rendered":"
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Farmaci<\/h1>\n
\n

Registrazione FDA (U.S. Food and Drug Administration)<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner]
Iniziare<\/span><\/div>
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Registrazione
\ne Listing<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]A tutti i proprietari e operatori di stabilimenti farmaceutici, statunitensi e non, che sono coinvolti nella produzione, preparazione,diffusione, assemblaggio o processamento di farmaci \u00e9 richiesto di registrarsi alla FDA e sottomettere una lista di ogni farmaco commercializzato negli Stati Uniti.[\/vc_column_text][vc_column_text el_class=”side-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side mobile-reverse”][vc_column width=”1\/2″ el_class=”side-left align-left” css=”.vc_custom_1581877147665{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-text-block font-white”]La U.S. FDA richiede che le etichette dei farmaci siano inviate alla U.S. FDA usando il linguaggio elettronico conosciuto come Extensible Markup Language (XML) nel formato Structured Product Labeling (SPL). Registrar Corp pu\u00f3 aiutarvi a modificare le vostre etichette affinch\u00e9 siano conformi ai requisiti della FDA. Il servizio di revisione delle etichette di Registrar Corp include un file grafico pronto per la stampa e un rapporto dettagliato con la regolamentazione, le linee guida, esempi di warning letter e di import alert ed altri documenti rilasciati dalla U.S. FDA.[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left hasImage” css=”.vc_custom_1581877157753{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/drug-label-scaled.jpg?id=41281) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Revisione etichette
\ne ingredienti<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581877512373{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/03\/fda-drug-master.jpg?id=40102) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Drug Master
\nFiles<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]Un Drug Master File \u00e8 una sottomissione di documentazione alla U.S. FDA che puo\u2019 essere utilizzata a supporto della richiesta di entrata sul mercato di un farmaco. Tale sottomissione fornisce informazioni dettagliate e confidenziali sulle strutture, i processi o gli articoli utilizzati nel processo di produzione, trasformazione, imballo o stoccaggio di uno o pi\u00f9 farmaci. Gli specialisti di Registrar Corp forniscono indicazioni in merito agli elementi richiesti, i formati e le particolarit\u00e0 di presentazione di un Drug Master File.[\/vc_column_text][vc_column_text el_class=”side-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section css=”.vc_custom_1574176315943{background-color: #ececec !important;}”][vc_row equal_height=”yes” el_class=”grid-tiles”][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1613484682911{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/adverse-event-scaled.jpg?id=41239) !important;}” el_class=”grid-tile-title hasImage”]\n

Contatto eventi avversi per farmaci generici<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]La FDA richiede che le etichette di farmaci da banco messi in commercio senza una richiesta approvata riportino un indirizzo o numero di telefono americano per ricevere i reclami dei consumatori in caso di gravi eventi avversi. Registrar Corp pu\u00f2 agire come vostro contatto statunitense per il tempestivo inoltro dei reclami alla vostra azienda, cos\u00ec come richiesto dalla FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963753672{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/08\/drug-labels-new-product.jpg?id=40003) !important;}” el_class=”grid-tile-title hasImage”]\n

Requisiti per stabilimenti di Outsourcing<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Le aziende farmaceutiche che sono registrate come Stabilimenti di Outsourcing presso la U.S. Food and Drug Administration (FDA) possono ottenere un\u2019esenzione da alcuni requisiti di approvazione ed etichettatura della FDA. Gli specialisti di Registrar Corp possono registrare le aziende come Stabilimenti di Outsourcing e offrire assistenza in merito ai requisiti della FDA, incluso l’invio dei rapporti annuali per i farmaci.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963787986{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/10\/VoluntaryMalfunctionSummary.jpg?id=39819) !important;}” el_class=”grid-tile-title hasImage”]\n

\u00a0Auto-certificazione per farmaci generici<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Gli operatori del settore dei farmaci generici e dei farmaci denominati API hanno l\u2019obbligo di sottomettere un\u2019auto-certificazione alla FDA, nel periodo compreso tra il 1\u00b0 Maggio e il 1\u00b0 giugno di ogni anno.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-offset-0 vc_col-lg-4 vc_col-md-offset-0 vc_col-md-6 vc_col-sm-offset-0 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963820498{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/01\/container-yard.png?id=39392) !important;}” el_class=”grid-tile-title hasImage”]\n

3PL\/WDD Reporting<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]La U.S. FDA richiede alle aziende terze di logistica (Third-Party Logistics o 3PL) e ai distributori all\u2019ingrosso di farmaci (Wholesale Drug Distributors o WDD) di segnalare la licenza statale e altre informazioni relative a tutte le loro aziende tra il 1\u00ba gennaio e il 31 marzo di ogni anno.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963858746{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/detention-scaled.jpg?id=41099) !important;}” el_class=”grid-tile-title hasImage”]\n

Assistenza detenzioni U.S. FDA<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Le aziende che esportano verso gli Stati Uniti possono trovarsi ad avere i propri prodotti bloccati all’ingresso senza previo controllo fisico dalla FDA. I prodotti soggetti a “Detention Without Physical Examination” (DWPE) sono trattenuti al porto di entrata mentre la FDA esegue controlli, analisi e test aggiuntivi. I ritardi causati dalla DWPE possono essere lunghi, specialmente per le aziende che hanno delle scadenze di consegna.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1582215252079{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive.jpg?id=41657) !important;}” el_class=”grid-tile-title hasImage”]\n

Requisiti per additivi coloranti<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Un colorante farmaceutico additivo \u00e9 qualsiasi tintura, pigmento o altra sostanza in grado di attribuire colore a un farmaco. I coloranti farmaceutici additivi sono regolamentati dalla FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][vc_column offset=”vc_col-lg-offset-4 vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581963934321{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/export-certs-scaled.jpg?id=41085) !important;}” el_class=”grid-tile-title hasImage”]\n

Export Certificate per governi stranieri<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Gli stabilimenti statunitensi che esportano all\u2019estero ricevono spesso la richiesta dei propri clienti o dei governi extra-nazionali di poter fornire un \u201cExport Certificate\u201d, relativamente ai prodotti regolati dalla normativa U.S. FDA. L\u2019Export Certificate \u00e8 un documento preparato dalla U.S. FDA che contiene le informazioni relative alla normativa specifica applicabile al prodotto e allo status di commercializzazione.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniziare<\/a><\/p>\n

Costi<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_row][vc_column]

<\/i><\/i><\/div><\/div><\/div>
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[vc_section el_id=”pageHero” css=”.vc_custom_1581876736941{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/drug-hero-1.jpg?id=41267) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” el_class=”page-solutions”][vc_row el_class=”page-marquee”][vc_column][vc_column_text el_class=”half-width”] Farmaci Registrazione FDA (U.S. Food and Drug Administration) [\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=”hero-footer”][vc_column][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJzb2x1dGlvbnMtaGVyby1mb290ZXIlMjIlM0UlMEElM0NzcGFuJTIwY2xhc3MlM0QlMjJ0ZXh0JTIyJTNFTm9uJTIwc2FpJTIwZGElMjBkb3ZlJTIwaW5pemlhcmUlM0YlM0MlMkZzcGFuJTNFJTBBJTNDYSUyMGhyZWYlM0QlMjIlMjMlMjIlMjBjbGFzcyUzRCUyMmNoYXQtYnRuJTIwYnRuLWJsdWUtd2hpdGUlMjBidG4tZmxleCUyMiUzRSUwQSUzQ2ltZyUyMHNyYyUzRCUyMiUyRndwLWNvbnRlbnQlMkZ1cGxvYWRzJTJGMjAxOSUyRjEwJTJGQ2hhdF9idWJibGUucG5nJTIyJTIwJTJGJTNFJTBBJTNDc3BhbiUzRUFjY2VkaSUyMGFsbGElMjBjaGF0JTNDJTJGc3BhbiUzRSUwQSUzQyUyRmElM0UlMEElM0MlMkZkaXYlM0U=[\/vc_raw_html][\/vc_column][\/vc_row][\/vc_section][vc_section el_id=”featuredSolutions”][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581876926633{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/drug-registration-scaled.jpg?id=41274) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”] Registrazione e Listing [\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]A tutti i proprietari e operatori di<\/p>\n","protected":false},"author":2,"featured_media":402,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"full-width-page.php","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"class_list":["post-41338","page","type-page","status-publish","has-post-thumbnail","entry"],"yoast_head":"\nFarmaci - 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