{"id":41336,"date":"2016-08-30T19:40:03","date_gmt":"2016-08-30T23:40:03","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-drugs\/"},"modified":"2021-07-27T08:58:32","modified_gmt":"2021-07-27T12:58:32","slug":"fda-drugs","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/fr\/fda-drugs\/","title":{"rendered":"Produits pharmaceutiques"},"content":{"rendered":"
[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”]\n

Produits pharmaceutiques<\/h1>\n
\n

S\u2019enregistrer avec l\u2019U.S. Food and Drug Administration (FDA)<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner]
Commencer<\/span><\/div>
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Enregistrements d’\u00e9tablissements
\net de produits pharmaceutiques<\/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”]Les propri\u00e9taires ou op\u00e9rateurs de tout \u00e9tablissement pharmaceutique U.S. et non-U.S. qui sont engag\u00e9s dans la fabrication, pr\u00e9paration, propagation, composition, ou traitement de produits pharmaceutiques ont l\u2019obligation de s\u2019enregistrer et de soumettre une liste de tout produit pharmaceutique en distribution commerciale aux \u00c9tats-Unis.[\/vc_column_text][vc_column_text el_class=”side-links”]Commencer<\/a><\/p>\n

Tarifs<\/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 FDA exige que les \u00e9tiquetages de produits pharmaceutiques soient index\u00e9s en utilisant le langage Extensible Markup Language (XML) dans le format Structured Product Labeling (SPL). Registrar Corp peut aider \u00e0 modifier votre \u00e9tiquetage de produit pharmaceutique pour satisfaire les r\u00e8glementations FDA. Registrar Corp fournit des fichiers graphiques pr\u00eats \u00e0 \u00eatre imprim\u00e9s ou modifi\u00e9s ainsi qu\u2019un rapport qui d\u00e9taille les r\u00e9glementations, guides de conformit\u00e9, lettres d\u2019avertissements, alertes d\u2019importations et autres documents de r\u00e9f\u00e9rence \u00e9mis par l\u2019U.S. FDA.[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Commencer<\/a><\/p>\n

Tarifs<\/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

V\u00e9rification d\u2019\u00e9tiquetage
\net d\u2019ingr\u00e9dients<\/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

Master File
\nProduit pharmaceutique<\/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 Master File de produit pharmaceutique est une soumission \u00e0 la FDA qui peut \u00eatre utilis\u00e9e en support d\u2019une soumission d\u2019avant mise sur le march\u00e9 pour fournir des informations confidentielles et d\u00e9taill\u00e9s \u00e0 propos d\u2019un \u00e9tablissement, des processus, ou des articles utilis\u00e9s dans la production, le traitement, le packaging, et le stockage d\u2019un produit pharmaceutique ou plus. L\u2019\u00e9quipe de sp\u00e9cialistes r\u00e8glementaire de Registrar Corp fournissent des conseils sur les \u00e9l\u00e9ments requis, formats, et particularit\u00e9s d\u2019une soumissions de Master File de produit pharmaceutique.[\/vc_column_text][vc_column_text el_class=”side-links”]Commencer<\/a><\/p>\n

Tarifs<\/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_1591640747197{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

Contact en Cas d\u2019\u00e9v\u00e9nements Ind\u00e9sirables<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]La FDA exige que les \u00e9tiquettes des m\u00e9dicaments en vente libre commercialis\u00e9s sans autorisation de mise sur le march\u00e9 approuv\u00e9e comportent une adresse ou un num\u00e9ro de t\u00e9l\u00e9phone aux \u00c9tats-Unis pour recevoir les rapports des consommateurs sur les \u00e9v\u00e9nements ind\u00e9sirables graves. Registrar Corp peut servir de contact aux \u00c9tats-Unis pour la transmission en temps opportun des rapports des consommateurs \u00e0 votre entreprise, comme l’exige la FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/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_1581877433799{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

R\u00e8glementations FDA \u00e9tablissement de pr\u00e9parations de m\u00e9dicaments<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Les \u00e9tablissement de pr\u00e9parations de m\u00e9dicaments enregistr\u00e9s comme Outsourcing Facilities avec l\u2019U.S. Food and Drug Administration (FDA) peuvent \u00eatre exempt\u00e9s de certaines exigences d\u2019approbation et d\u2019\u00e9tiquetage de la FDA. L\u2019\u00e9quipe de sp\u00e9cialistes r\u00e8glementaire de Registrar Corp peut enregistrer les pharmacies comme Outsourcing Facilities et les aider \u00e0 satisfaire les r\u00e8glementations FDA pour cet enregistrement, incluant la soumissions de rapports annuels de produit pharmaceutiques.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/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_1581877250425{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/10\/VoluntaryMalfunctionSummary.jpg?id=39819) !important;}” el_class=”grid-tile-title hasImage”]\n

Exigences de Self-Identification pour les \u00e9tablissements producteurs de m\u00e9dicaments g\u00e9n\u00e9riques<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Les op\u00e9rateurs d\u2019\u00e9tablissements pharmaceutiques produisant des m\u00e9dicaments g\u00e9n\u00e9riques ou substances actives g\u00e9n\u00e9riques doivent soumettre des informations de \u201cself-identification\u201d \u00e0 la FDA entre le 1er Mai et le 1er Juin de chaque ann\u00e9e.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/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_1581959230572{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

U.S. FDA Reportings 3PL\/WDD<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]L\u2019U.S. FDA oblige les fournisseurs tierces parties logistique (Third-Party Logistics \u2013 3PL) et les Distributeurs de m\u00e9dicaments en gros (Wholesale Drug Distributors \u2013 WDD) \u00e0 reporter un permis d\u2019exercer d\u2019\u00e9tat et autres informations pour tous leurs \u00e9tablissements entre le 1er Janvier et le 31 Mars.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/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_1581877298597{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

Assistance d\u00e9tention<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Les entreprises envoyant des produits vers les \u00c9tats-Unis peuvent avoir leurs cargaisons sujettes \u00e0 la d\u00e9tention sans examen physiques (Detention without physical examination \u2013 DWPE) par la FDA. Les produits sujets \u00e0 la DWPE sont d\u00e9tenus au port d\u2019entr\u00e9e pendant que la FDA effectue des examens minutieux, tests, et analyse additionnels. Les retards d\u00fbs \u00e0 la DWPE peuvent \u00eatre longs pour les entreprises devant livrer leurs produits dans les d\u00e9lais.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/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_1582215131542{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive.jpg?id=41655) !important;}” el_class=”grid-tile-title hasImage”]\n

Exigences pour les colorants<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Un colorant de produit pharmaceutique est tout pigment, teinture, ou autre substance qui peuvent donner de la couleur \u00e0 un produit pharmaceutique. Les colorants de produit pharmaceutique sont r\u00e9gul\u00e9s par la FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

Tarifs<\/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_1581957970422{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

Certificats d’exportations aux gouvernements \u00e9trangers<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Les clients et gouvernements \u00e9trangers demandent souvent aux entreprises exportant des produits depuis les \u00c9tats-Unis de fournir un \u201cExport Certificate\u201d (certificat d\u2019exportation) pour les produits r\u00e9gul\u00e9s par l\u2019U.S. FDA. Un Certificat d\u2019Exportation est un document pr\u00e9par\u00e9 par l\u2019U.S. FDA contenant des informations sur le statut r\u00e8glementaire ou marketing d\u2019un produit.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Commencer<\/a><\/p>\n

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

<\/i><\/i><\/div><\/div><\/div>
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<\/div>[\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

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