[vc_section full_width=”stretch_row” css=”.vc_custom_1531383666095{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;background-position: 0 0 !important;background-repeat: no-repeat !important;}”][vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” el_class=”background-position-left-top” css=”.vc_custom_1532168119330{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 82px !important;padding-bottom: 48px !important;background-position: 0 0 !important;background-repeat: no-repeat !important;}”][vc_column width=”1\/2″ css=”.vc_custom_1531387745299{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_single_image image=”8359″ img_size=”full” css=”.vc_custom_1576450577019{margin-top: 0px !important;margin-bottom: 15px !important;padding-top: 0px !important;padding-bottom: 0px !important;}” el_class=”full-width-image”][\/vc_column][vc_column css_animation=”none” width=”1\/2″ css=”.vc_custom_1533793643137{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-right: 30px !important;padding-bottom: 0px !important;padding-left: 30px !important;}”][vc_custom_heading source=”post_title” font_container=”tag:h3|font_size:40px|text_align:left|color:%232d2d2d|line_height:50px” use_theme_fonts=”yes” css_animation=”none” el_class=”font-weight-extrabold” css=”.vc_custom_1533793464458{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 13px !important;}”][vc_custom_heading text=”Prescription only and over-the-counter medicines” font_container=”tag:h3|font_size:18px|text_align:left|color:%2302646f|line_height:25px” use_theme_fonts=”yes” css_animation=”none” el_class=”font-weight-semibold” css=”.vc_custom_1576450859070{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 18px !important;}”][vc_column_text css_animation=”none” css=”.vc_custom_1576450714468{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 20px !important;}”]\u2022 Advising on the most appropriate route for submission throughout Europe (national, Decentralised, Mutual Recognition or Centralised), considering the pros and cons of each
\n\u2022 Advise on scenarios around life-cycle planning
\n\u2022 Regulatory life-cycle management, including:
\n\u2013 Type I\/minor variations
\n\u2013 Type II\/major variations
\n\u2013 Renewals
\n\u2013 Periodic safety update reports
\n\u2013 Line extensions
\n\u2013 Deregistration\/discontinuation
\n\u2022 Handling of responses to questions from health authorities
\n\u2022 Packaging activities such as packaging change requests based on labelling changes, artwork updates, and mock-up preparation
\n\u2022 Translation activities
\n\u2022 Approval management
\n\u2022 Handling of post-approval commitments
\n\u2022 Providing regulatory intelligence with regard to new or revised legislation
\nProcesses are in place to make sure that safety changes and other changes get communicated to the client\u2019s global regulatory affairs, that there is regular liaison with the affiliate as required, and that any deficiency letters get quickly reported to headquarters.
\nKPIs are established to determine whether project objectives are being met. KPIs include:
\n\u2022 Communication via meetings, status reports, and progress reports
\n\u2022 Evaluation of regulatory submission timelines
\n\u2022 Quality of information collection and application content
\n\u2022 Packaging materials that reflect current requirements for specific individual markets
\n\u2022 Tools for archiving of relevant documents in the client\u2019s database[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
[vc_section full_width=”stretch_row” css=”.vc_custom_1531383666095{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;background-position: 0 0 !important;background-repeat: no-repeat !important;}”][vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” el_class=”background-position-left-top” css=”.vc_custom_1532168119330{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 82px !important;padding-bottom: 48px !important;background-position: 0 0 !important;background-repeat: no-repeat !important;}”][vc_column width=”1\/2″ css=”.vc_custom_1531387745299{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_single_image image=”8359″ img_size=”full” css=”.vc_custom_1576450577019{margin-top: 0px !important;margin-bottom: 15px !important;padding-top: 0px !important;padding-bottom: 0px !important;}” […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7970,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-8016","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/pages\/8016","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/comments?post=8016"}],"version-history":[{"count":6,"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/pages\/8016\/revisions"}],"predecessor-version":[{"id":8418,"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/pages\/8016\/revisions\/8418"}],"up":[{"embeddable":true,"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/pages\/7970"}],"wp:attachment":[{"href":"http:\/\/pharmaconsultant.eu\/en\/wp-json\/wp\/v2\/media?parent=8016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}