{"id":30,"date":"2013-02-11T09:49:30","date_gmt":"2013-02-11T13:49:30","guid":{"rendered":"https:\/\/www.regulatoryaffairs.com\/?page_id=30"},"modified":"2019-05-10T11:14:27","modified_gmt":"2019-05-10T15:14:27","slug":"faq","status":"publish","type":"page","link":"https:\/\/www.regulatoryaffairs.com\/faq\/","title":{"rendered":"FAQ"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:30px;padding-bottom:0px;padding-left:30px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;\" ><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=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><style type=\"text\/css\">.fusion-accordian #accordian-1 .panel-title a .fa-fusion-box:before{ font-size: 13px;}.fusion-accordian #accordian-1 .panel-title a .fa-fusion-box{ color: #ffffff;}.fusion-accordian #accordian-1 .panel-title a{font-size:24px;}.fusion-accordian #accordian-1 .fa-fusion-box { background-color: #333333;border-color: #333333;}.fusion-accordian #accordian-1 .panel-title a:hover,.fusion-accordian #accordian-1 .panel-title a.hover { color: #25afb4;}.fusion-faq-shortcode .fusion-accordian #accordian-1 .fusion-toggle-boxed-mode:hover .panel-title a { color: #25afb4;}.fusion-accordian #accordian-1 .panel-title .active .fa-fusion-box,.fusion-accordian #accordian-1 .panel-title a:hover .fa-fusion-box,.fusion-accordian #accordian-1 .panel-title a.hover .fa-fusion-box { background-color: #25afb4!important;border-color: #25afb4!important;}<\/style><div class=\"fusion-faq-shortcode\"><div class=\"fusion-faqs-wrapper\"><div class=\"accordian fusion-accordian\"><div class=\"panel-group \" id=\"accordian-1\"><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-793 \"><span class=\"entry-title rich-snippet-hidden\">How do we get started?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-04-30T10:03:54-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-793\" href=\"#collapse-1-793\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">How do we get started?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-793\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><p>As everyone knows, we start with a Non-disclosure agreement and we prefer that those agreements are 2 way, however.\u00a0\u00a0 We can use our standard agreement or a specific agreement to your company.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-795 \"><span class=\"entry-title rich-snippet-hidden\">What is your technical or regulatory strength?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-04-30T10:04:15-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-795\" href=\"#collapse-1-795\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is your technical or regulatory strength?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-795\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><p>We have filed many INDs from paper to eCTD.\u00a0 We enjoy solving early development issues and managing risk while maintaining patient safety and optimal data acquisition.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-797 \"><span class=\"entry-title rich-snippet-hidden\">What are your weaknesses ?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-04-30T10:04:31-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-797\" href=\"#collapse-1-797\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What are your weaknesses ?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-797\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><p>We do not enjoy the ANDA process.\u00a0 We feel that this has become more of a legal landscape rather than a science-driven process.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-799 \"><span class=\"entry-title rich-snippet-hidden\">Do you have secure email?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-04-30T10:04:53-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-799\" href=\"#collapse-1-799\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">Do you have secure email?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-799\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><p>Yes, we do.\u00a0 We have a hosted MS Exchange server off-site and on-site. We typically use the off-site server and will provide you with those addresses once our collaboration begins.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-801 \"><span class=\"entry-title rich-snippet-hidden\">How are documents shared?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-04-30T10:05:06-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-801\" href=\"#collapse-1-801\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">How are documents shared?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-801\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><p>We prefer that for confidential information that you \u201cpost\u201d your documents to our servers or a hosted server certified by us.\u00a0 In this way, we can control their distribution.\u00a0 Once we download them, they only reside on our computers.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-803 \"><span class=\"entry-title rich-snippet-hidden\">What is the best way to contact you?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-04-30T10:05:19-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-803\" href=\"#collapse-1-803\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is the best way to contact you?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-803\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><p>Email is the best way to contact us as we are mobile and in constant contact with our office.\u00a0\u00a0 We will provide those instructions to you.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-805 \"><span class=\"entry-title rich-snippet-hidden\">Do you work with start-up companies?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-04-30T10:05:31-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-805\" href=\"#collapse-1-805\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">Do you work with start-up companies?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-805\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><p>Yes, we do.\u00a0 And we like to work with start-up companies.\u00a0 But we like to work in a fairly structured way when necessary so that we know that we are adding value to your company and or product.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-807 \"><span class=\"entry-title rich-snippet-hidden\">Do you work with non-US companies?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-10-17T16:46:55-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-807\" href=\"#collapse-1-807\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">Do you work with non-US companies?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-807\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1-1 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:30px;padding-bottom:0px;padding-left:30px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-1\"><p>Yes, we do and we like it. \u00a0Our experience has been extensive with our friends in Europe and Asia.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-faq-post fusion-faq-post-809 \"><span class=\"entry-title rich-snippet-hidden\">Do you work for investment companies or groups?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/www.regulatoryaffairs.com\/author\/mjjdesigns\/\" title=\"Posts by MJJDesigns\" rel=\"author\">MJJDesigns<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2019-04-30T10:06:17-04:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-809\" href=\"#collapse-1-809\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">Do you work for investment companies or groups?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-809\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><p>Yes, we do.\u00a0 We can and have provided the following: Risk Assessment and Regulatory Success Probability &amp; Due Diligence for Product or Company Acquisition<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":{"_acf_changed":false,"footnotes":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FAQ - Clementi &amp; Associates<\/title>\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.regulatoryaffairs.com\/faq\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FAQ - Clementi &amp; Associates\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.regulatoryaffairs.com\/faq\/\" \/>\n<meta property=\"og:site_name\" content=\"Clementi &amp; 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