What it is about<\/b><\/p>\n
In the pharmaceutical sector, Pharmacovigilance is a central element for safeguarding public health, protecting patients, and ensuring the sustainability of products on the market. Managing quality in Pharmacovigilance proactively means preventing critical issues, improving system performance, and approaching audits and inspections with confidence and awareness.<\/p>\n Our strengths<\/b> ➕<\/span> Technical and cross-functional expertise<\/b>: we have professionals experienced in the management of Pharmacovigilance Quality Systems, Quality Assurance and Audits (training, SOP development, vendor qualification, KPI identification and management, audit program definition and execution, deviation management and CAPAs), as well as continuous improvement processes (system reviews, compliance assessments and implementation of remediation plans), capable of integrating quality into daily operational activities.<\/span><\/p>\n ➕<\/span> Qualified, timely, flexible and tailored service<\/b>: we operate as an extension of your team, supporting you through every phase \u2013 from initial gap assessments to the identification of training needs and SOP development, from risk analysis to the design of strategic and tactical audit programs \u2013 with an approach focused on your organization, product portfolio and business needs.<\/p>\n ➕<\/span> Inspection Readiness<\/i><\/b>: through our strategy, expertise and services, we support companies in preparing for Pharmacovigilance Inspections and managing all required follow-up activities (from finding<\/i> assessment to root-cause analysis<\/i><\/span> and CAPA Plan management, mock inspections<\/i> and PSMF review<\/span>).<\/p>\n How we can help you<\/b> What we can do<\/b><\/p>\n ✅ <\/span>Quality<\/b><\/b><\/p>\n ✅ <\/span>Training and quality culture in Pharmacovigilance:<\/b><\/b><\/p>\n Products covered<\/b> Who it is for<\/b> [vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” scene_position=”center” text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” overlay_strength=”0.3″ gradient_direction=”left_to_right” shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none”…<\/p>\n","protected":false},"author":1,"featured_media":10107,"parent":0,"menu_order":18,"comment_status":"closed","ping_status":"closed","template":"page-sidebar.php","meta":{"footnotes":""},"class_list":["post-10009","page","type-page","status-publish","has-post-thumbnail"],"yoast_head":"\n
\n<\/span>A well-structured and robust Pharmacovigilance Quality System ensures traceable processes, reliable data, and effective risk management, guaranteeing full compliance with current regulations and Good Pharmacovigilance Practices (GVP).<\/p>\n
\n➕<\/span> Strategic approach<\/b>: we support companies in the interpretation and application of Pharmacovigilance regulations and guidelines (EU Legislation, GVP, ICH guidelines), with the aim of ensuring the implementation of an appropriate and effective Quality System and guaranteeing compliance with the obligations required of Marketing Authorization Holders (MAHs).<\/p>\n
\nWe can provide you with a team of experts or Auditors, or directly assume the role of Quality Assurance Manager <\/i>for Pharmacovigilance<\/i><\/i><\/span><\/p>\n\n
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\n✅<\/span> Development and authorized medicinal products<\/p>\n
\n✅<\/span> Italian and international companies
\n✅<\/span> Companies holding Marketing Authorizations (MAHs) in Italy and abroad<\/p>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” scene_position=”center” text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” overlay_strength=”0.3″ gradient_direction=”left_to_right” shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"