{"id":167,"date":"2019-10-09T17:57:23","date_gmt":"2019-10-09T14:57:23","guid":{"rendered":"http:\/\/cratia.com\/?p=167"},"modified":"2020-11-18T16:21:19","modified_gmt":"2020-11-18T14:21:19","slug":"razrabotka-chastej-dose","status":"publish","type":"post","link":"https:\/\/cratia.com\/en\/uslugi\/lekarstvennye-sredstva\/razrabotka-chastej-dose\/","title":{"rendered":"Medical and safety expert writing"},"content":{"rendered":"<p><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">For more than 10 years we perform medical, technical and safety writing for national and international manufacturers. We have deep knowledge in national and international legislation, extensive experience and are responsible for the result.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">We use our own writers or select external experts with professional experience and scientific knowledge in the necessary areas of medicine. We can do the work based on your template or use national and international regulatory documents and guidelines. Any work performed by us undergoes thorough scientific and editorial verification, independent quality control.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">We are experienced in writing of the following documents:\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\"> <b>I. <\/b><\/span><b>Parts of the registration dossier in CTD format:<\/b><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Module 1.8.2. Risk Management Plan;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Module 2.3. Quality Overall Summary;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Module 2.4. Non-clinical Overview;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Module 2.5. Clinical Overview;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Module 2.6. Non-clinical Summary;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Module 2.7. Clinical Summary;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Module 4. Non-clinical Data;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Module 5. Clinical Data;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Search and selection of literature data for the Modules 4 and 5.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\"> <b>II.<\/b><\/span><b>Safety Documentation:<\/b><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">1.8.2. Risk Management Plan;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Addendum to Clinical Overview;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Periodic Safety Update Report (PSUR);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Periodic Benefit-risk Evaluation Report (PBRER);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Pharmacovigilance System Master File, SOPs.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\"><b>III. National works to be submitted in a specific country:<\/b><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Verification of the dossier for compliance with national requirements (feasibility study);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Translation of necessary parts, development of national documents and drafting the registration dossier;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of instructions for use (leaflet);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of packaging labeling;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of quality control methods (regulatory document);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Adapting EU RMP or Core RMP to national requirements;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Pharmacoeconomic and medical analysis and justification for inclusion in the list of essential medicinal products.\u00a0<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Cratia Ltd. performs expert work on the development of parts of the registration dossier in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, Ukraine and the Eurasian Economic Union. We are well versed in the national legislation, we have the necessary experience and resources for work performance.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: <a href=\"mailto:info@cratia.ua\">info@cratia.ua<\/a>, or visit <a href=\"\/en\/contacts\/\">our office<\/a>.\u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>For more than 10 years we perform medical, technical and safety writing for national and international manufacturers. We have deep knowledge in national and international legislation, extensive experience and are responsible for the result. We use our own writers or select external experts with professional experience and scientific knowledge in the necessary areas of medicine. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12,20],"tags":[],"class_list":["post-167","post","type-post","status-publish","format-standard","hentry","category-lekarstvennye-sredstva","category-uslugi"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/posts\/167","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/comments?post=167"}],"version-history":[{"count":13,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/posts\/167\/revisions"}],"predecessor-version":[{"id":1885,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/posts\/167\/revisions\/1885"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=167"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/categories?post=167"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/tags?post=167"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}