{"id":7464,"date":"2021-10-19T17:52:10","date_gmt":"2021-10-19T20:52:10","guid":{"rendered":"https:\/\/passarini.com.br\/portfolio-items\/fda-registration-2\/"},"modified":"2022-12-02T09:52:14","modified_gmt":"2022-12-02T12:52:14","slug":"fda-approval","status":"publish","type":"avada_portfolio","link":"https:\/\/passarini.com.br\/en\/portfolio-items\/fda-approval\/","title":{"rendered":"FDA Approval"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-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;\" id=\"quem-somos-banner-container\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-size:cover;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\" id=\"quem-somos-slider\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en.webp\" alt=\"Banner for FDA Approval\" width=\"1920\" height=\"500\" class=\"wp-image-10177\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/10\/1920x500-banner-estados-unidos-aplicacao-fda-en.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling fusion-equal-height-columns\" style=\"--awb-background-position:left top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--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-padding-top:60px;--awb-padding-bottom:100px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_2_3 2_3 fusion-two-third fusion-column-first\" style=\"--awb-padding-top:40px;--awb-padding-right:40px;--awb-padding-bottom:40px;--awb-padding-left:40px;--awb-bg-color:#ffffff;--awb-bg-color-hover:#ffffff;--awb-bg-size:cover;--awb-border-color:#dddddd;--awb-border-top:1px;--awb-border-right:1px;--awb-border-bottom:1px;--awb-border-left:1px;--awb-border-style:solid;width:65.3333%; margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 80; line-height: 1;\" data-fontsize=\"80\" data-lineheight=\"80px\">FDA Approval With Passarini<\/h2>\n<h3><b>What is <\/b><b>FDA Approval<\/b><b>?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">When a product is termed as <\/span><span style=\"font-weight: 400;\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration\">FDA<\/a> approved<\/span><span style=\"font-weight: 400;\"> in the US, it means that data on the product\u2019s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.<\/span><\/p>\n<h3><b>USA Commercialization and <\/b><b>FDA Approval<\/b><b>:<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">If your company is interested in USA commercialization and getting your products <\/span><span style=\"font-weight: 400;\">FDA approved<\/span><span style=\"font-weight: 400;\">, we have the ideal solution. Check all the services we provide for this market below.<\/span><\/p>\n<\/div><div class=\"fusion-text fusion-text-2\"><h3><b>1. USA Product and <\/b><b>FDA Registration<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Passarini Regulatory Affairs division has a team of specialists trained in a variety of issues related to consulting and advising for the FDA. Our specialists have already conducted several processes with the FDA and are able to provide the best service to help you get <\/span><span style=\"font-weight: 400;\">FDA registration<\/span><span style=\"font-weight: 400;\"> to market your products in the United States of America.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Some of the services in our portfolio include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Product Classification based on FDA criteria<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identifying whether there is a similar product registered to determine the possibility of preparing for the 510K process<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Determining all regulations applicable to your product<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Comparative analysis of the product with any similar product already registered<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sending the process for protocol with the FDA.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Once your product passes the<\/span><span style=\"font-weight: 400;\"> FDA registration<\/span><span style=\"font-weight: 400;\"> process, the certification has no expiration date and will be maintained as long as the company pays the annual fee for the renewal of the product.<\/span><\/p>\n<\/div><div class=\"fusion-text fusion-text-3\"><h3><b>2. USA Regulation<\/b><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/passarini.com.br\/en\/united-states-of-america\/market-analysis-health-regulation\/\"><span style=\"font-weight: 400;\">Market Analysis &#8211; USA Sanitary Regulations<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/passarini.com.br\/en\/united-states-of-america\/audits-in-conformity-with-the-qms\/\"><span style=\"font-weight: 400;\">Audits and Quality System<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/passarini.com.br\/en\/united-states-of-america\/510k-approved\/\"><span style=\"font-weight: 400;\">510 k approved<\/span><\/a><\/li>\n<\/ul>\n<p><span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/en\/contact\/\">Learn more about our FDA approval consulting and regulatory advisory services by contacting us today.<\/a><\/strong><\/span><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:30px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_3 1_3 fusion-one-third fusion-column-last\" style=\"--awb-padding-top:30px;--awb-padding-right:30px;--awb-padding-bottom:30px;--awb-padding-left:30px;--awb-bg-color:#ffffff;--awb-bg-color-hover:#ffffff;--awb-bg-size:cover;--awb-border-color:#dddddd;--awb-border-top:1px;--awb-border-right:1px;--awb-border-bottom:1px;--awb-border-left:1px;--awb-border-style:solid;width:30.6666%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-widget-area awb-widget-area-element fusion-widget-area-1 fusion-content-widget-area\" 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