{"id":963,"date":"2019-07-15T14:46:51","date_gmt":"2019-07-15T14:46:51","guid":{"rendered":"http:\/\/pastparallel.com\/axis\/?page_id=963"},"modified":"2023-11-16T10:03:52","modified_gmt":"2023-11-16T10:03:52","slug":"news-media","status":"publish","type":"page","link":"https:\/\/axisclinicals.com\/?page_id=963","title":{"rendered":"News &#038; Media"},"content":{"rendered":"<h2>Regulatory Inspections and Accreditations<\/h2>\n<p>AXIS Clinicals Limited conducted bioequivalence studies to support marketing authorization for various regulated markets including US FDA, Europe, TGA, ANVISA, WHO, DCGI, Health Canada, NPRA Malaysia, AEMPS Spain, INFARMED Portugal etc. for various sponsors. Our facility has been audited and approved by various global regulatory agencies and accreditation bodies and the details were described in the following table.<\/p>\n<p>For a summary of regulatory inspections and approvals <a href=\"http:\/\/axisclinicals.com\/wp-content\/uploads\/2023\/11\/Summary-of-Regulatory-Inspections-and-Approvals-Nov-2023.pdf\">Click here<\/a><\/p>\n<hr>\n<p><strong>US-FDA<\/strong>: 2nd to 6th March 2020, AXIS completed 34th Audit by US FDA<\/p>\n<p><strong>UK-MHRA<\/strong>: Dates: 4th to 8th  June 2018, AXIS completed 4th Audit by UK MHRA<\/p>\n<p><strong>WHO<\/strong>: Dates: 18th  to 21st  December 2017, AXIS completed 2nd  Audit by WHO<\/p>\n<p><strong>GCC-DR (Gulf Central Committee for Drug Registration)<\/strong>: Dates: 15th  to 16th February 2016 , Approved<\/p>\n<p><strong>MCC (Medicines Control Council) \u2013 South Africa<\/strong>: Dates: 25th to 27th March 2017, Approved<\/p>\n<p><strong>NPRA (National Pharmaceutical Regulatory Agency) \u2013 Malaysia:<\/strong> Dates: 18th \u2013 22nd June 2018 Approved<\/p>\n<p><strong>INFARMED (Portuguese National Authority of Medicines and Health Products):<\/strong> Dates: 18th &#8211;  20th  June 2018 Approved<\/p>\n<p><strong>AEMPS (Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios) \u2013 Spain:<\/strong> Dates: 17th  &#8211;  21st  Dec 2018 Approved<\/p>\n<hr>\n<h4>Events in 2020<\/h4>\n<p><strong>CPhI China 2020<\/strong><br \/>\nShanghai, China<br \/>\n16<sup>th<\/sup> &#8211; 18<sup>th<\/sup> December 2020<\/p>\n<p><strong>CPhI Worldwide 2020<\/strong><br \/>\nFiera Milano, Rho, Italy<br \/>\n31<sup>st<\/sup> August \u2013 02<sup>nd<\/sup> September 2021<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulatory Inspections and Accreditations AXIS Clinicals Limited conducted bioequivalence studies to support marketing authorization for various regulated markets including US FDA, Europe, TGA, ANVISA, WHO, DCGI, Health Canada, NPRA Malaysia, AEMPS Spain, INFARMED Portugal etc. for various sponsors. Our facility has been audited and approved by various global regulatory agencies and accreditation bodies and the &hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_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":"sidebar-content"},"_links":{"self":[{"href":"https:\/\/axisclinicals.com\/index.php?rest_route=\/wp\/v2\/pages\/963"}],"collection":[{"href":"https:\/\/axisclinicals.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/axisclinicals.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/axisclinicals.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/axisclinicals.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=963"}],"version-history":[{"count":16,"href":"https:\/\/axisclinicals.com\/index.php?rest_route=\/wp\/v2\/pages\/963\/revisions"}],"predecessor-version":[{"id":1400,"href":"https:\/\/axisclinicals.com\/index.php?rest_route=\/wp\/v2\/pages\/963\/revisions\/1400"}],"wp:attachment":[{"href":"https:\/\/axisclinicals.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=963"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}