{"id":3522,"date":"2022-03-02T14:47:28","date_gmt":"2022-03-02T14:47:28","guid":{"rendered":"https:\/\/pharma-expertise.com\/?page_id=3522"},"modified":"2022-10-26T13:26:58","modified_gmt":"2022-10-26T13:26:58","slug":"pharmaceuticals-regulatory-affairs","status":"publish","type":"page","link":"https:\/\/pharma-expertise.com\/en\/pharmaceuticals-regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"

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Regulatory Affairs<\/h2>\n

Our services for regulatory affairs<\/h1>\n

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The ever-increasing requirements for pharmaceuticals must be implemented in an efficient regulatory affairs strategy<\/strong>. In order to prove the efficacy and tolerability of your drug, a scientifically sound and regulatory safe approach, careful documentation for regulatory submissions, and professional management of clinical trials<\/strong><\/a> are required.<\/p>\n

This applies to new submissions through national approval procedures, MRP procedures (Mutual Recognition Procedure), DCP procedures (Decentralised Procedure), <\/strong>and CP procedures (Centralised Procedure).<\/strong> It also relevant to revisions of dossiers for new procedures or complex change notifications, variations including indication extension, change of contract manufacturer, change of primary packaging, new manufacturing method, a new name, claim changes, the change of a drug from Rx to OTC status, and marketing authorisation extensions (Renewal).<\/p>\n

Our project management<\/strong> accompanies you through individual variations<\/strong>. However, we also support the entire process<\/strong>, from the development of the strategy and its implementation to the submission and granting of marketing authorization. We also help you through our network to find another contract manufacturer, primary packaging material, other active ingredient manufacturers etc.<\/p>\n

We are happy to support you! Just contact us.<\/strong><\/p>\n

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Our Regulatory Affairs Services:<\/h2>\n

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Regulatory strategies, regulatory procedures<\/strong><\/p>\n

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Dossier preparation<\/strong>
and revision<\/strong>
(CTD, eCTD)<\/strong><\/p>\n

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Change notifications<\/strong>
(Variations)<\/strong><\/p>\n

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Authority discussions<\/strong>
(e.g. Scientific Advice<\/strong>)<\/p>\n

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Consulting<\/strong> on
clinical studies<\/strong>
in the approval process<\/strong><\/p>\n

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Expert opinions <\/strong>on preclinical (modules 2.4, 2.6 <\/strong>and 4), clinical (modules 2.5, 2.7 <\/strong>and 5),<\/strong> and\u00a0quality (modules 2.3 <\/strong>and 3)<\/strong><\/p>\n

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Medical opinions<\/strong>
on pharmacology<\/strong>, toxicology<\/strong>
and clinic<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

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Labelling<\/strong>
(preparation <\/strong>of package inserts <\/strong>and technical information), readability user test<\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” admin_label=”Services” _builder_version=”4.16″ max_width=”80%” custom_margin=”0px||0px||false|false” custom_padding=”0px||40px||false|false” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.17.3″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n

Creation<\/strong>
Investigational Medicinal Product Dossier (IMPD), Investigator Brochure (IB), study plan, study report form (CRF), final report,<\/strong> etc.<\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.17.3″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n

Due Diligence<\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

Regulatory Affairs Our services for regulatory affairsThe ever-increasing requirements for pharmaceuticals must be implemented in an efficient regulatory affairs strategy. In order to prove the efficacy and tolerability of your drug, a scientifically sound and regulatory safe approach, careful documentation for regulatory submissions, and professional management of clinical trials are required. This applies to new […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-3522","page","type-page","status-publish","hentry"],"yoast_head":"\nFDA approval \u00bb Drug Regulatory Affairs & FDA drug registration<\/title>\n<meta name=\"description\" content=\"Our drug regulatory affairs services: approval procedures \u2714 US FDA \u2714 European EMA \u2714 BfArM \u2714 DCP \u2714 MRP \u2714 CP \u2714 change notifications \u2794 Contact.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-expertise.com\/en\/pharmaceuticals-regulatory-affairs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" 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