{"id":53,"date":"2015-01-17T21:49:42","date_gmt":"2015-01-17T19:49:42","guid":{"rendered":"http:\/\/delfidanismanlik.com.tr\/en\/?page_id=53"},"modified":"2015-01-20T22:59:41","modified_gmt":"2015-01-20T20:59:41","slug":"regulatory-registration-consultancy","status":"publish","type":"page","link":"http:\/\/delfidanismanlik.com.tr\/en\/regulatory-registration-consultancy\/","title":{"rendered":"Regulatory &#038; Registration Consultancy"},"content":{"rendered":"<p>Powered by the efforts and diligence of our consultants, who have several years of pharmaceutical experiences in major companies, we offer the following short-listed services:<\/p>\n<ul>\n<li>Preparation of GMP Application Files<\/li>\n<\/ul>\n<ul>\n<li>Preparing registration\/regulatory files in e-CTD (Common Technical Document) format<\/li>\n<\/ul>\n<ul>\n<li>Compliance Analyses <em>(Detection of amendments\/modifications\/changes to PILs\/SmPCs through examination of CDS, CCSI and PIL documents) <\/em><\/li>\n<li>Preparing applications for Type I and Type II variations<\/li>\n<\/ul>\n<ul>\n<li>Preparation and Application of SmPCs and PILs<\/li>\n<\/ul>\n<ul>\n<li>Drug Reimbursement Applications<\/li>\n<\/ul>\n<ul>\n<li>Preparation of Summary Bridging Reports on Product Safety<\/li>\n<\/ul>\n<ul>\n<li>Entry of companies into the Turkish National Databank of Medical Devices and Drugs \u2013 T\u0130TUBB)<\/li>\n<\/ul>\n<ul>\n<li>Uploading documents and registering products at T\u0130TUBB portal.<\/li>\n<\/ul>\n<ul>\n<li>Preparation of medical device labels<\/li>\n<\/ul>\n<ul>\n<li>Medical device reimbursement files<em> (determining whether devices are in the positive listing of reimbursable products) <\/em><\/li>\n<\/ul>\n<ul>\n<li>Application for CE certificates<em> (obtaining CE certificates from authorised bodies in case of absence) <\/em><\/li>\n<\/ul>\n<p>Our regulatory services are not limited to the aforementioned. Please contact us for further details.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Powered by the efforts and diligence of our consultants, who have several years of pharmaceutical experiences in major companies, we offer the following short-listed services: Preparation of GMP Application Files Preparing registration\/regulatory files in e-CTD (Common Technical Document) format Compliance Analyses (Detection of amendments\/modifications\/changes to PILs\/SmPCs through examination of CDS, CCSI and PIL documents) Preparing <a class=\"read-more-link\" href=\"http:\/\/delfidanismanlik.com.tr\/en\/regulatory-registration-consultancy\/\"><br \/>read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"full-width.php","meta":{"footnotes":""},"_links":{"self":[{"href":"http:\/\/delfidanismanlik.com.tr\/en\/wp-json\/wp\/v2\/pages\/53"}],"collection":[{"href":"http:\/\/delfidanismanlik.com.tr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/delfidanismanlik.com.tr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/delfidanismanlik.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/delfidanismanlik.com.tr\/en\/wp-json\/wp\/v2\/comments?post=53"}],"version-history":[{"count":2,"href":"http:\/\/delfidanismanlik.com.tr\/en\/wp-json\/wp\/v2\/pages\/53\/revisions"}],"predecessor-version":[{"id":70,"href":"http:\/\/delfidanismanlik.com.tr\/en\/wp-json\/wp\/v2\/pages\/53\/revisions\/70"}],"wp:attachment":[{"href":"http:\/\/delfidanismanlik.com.tr\/en\/wp-json\/wp\/v2\/media?parent=53"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}