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data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-35ff744 elementor-widget elementor-widget-heading" data-id="35ff744" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">PHARMACOVIGILANCE</h1> </div> </div> <div class="elementor-element elementor-element-2e3bbaf e-flex e-con-boxed e-con e-child" data-id="2e3bbaf" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-ee4927e e-con-full e-flex e-con e-child" data-id="ee4927e" data-element_type="container"> <div class="elementor-element elementor-element-dcdf443 elementor-widget__width-initial elementor-widget elementor-widget-text-editor" data-id="dcdf443" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span class="s4">At Clinexel, we provide various services including </span><span class="s4">C</span><span class="s4">ase </span><span class="s4">P</span><span class="s4">rocessing, </span><span class="s4">R</span><span class="s4">egulatory </span><span class="s4">S</span><span class="s4">ubmissions, </span><span class="s4">A</span><span class="s4">ggregate </span><span class="s4">R</span><span class="s4">eports, </span><span class="s4">L</span><span class="s4">iterature </span><span class="s4">M</span><span class="s4">onitoring, </span><span class="s4">S</span><span class="s4">ignal </span><span class="s4">D</span><span class="s4">etection and Risk Management Plans (RMPs). We conduct GVP audits and provide QPPV services in several countries.</span></p> </div> </div> <div class="elementor-element elementor-element-25a9242 elementor-widget elementor-widget-button" data-id="25a9242" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us/"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Talk to Our Experts</span> </span> </a> </div> </div> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-782953f e-con-full e-flex e-con e-parent" data-id="782953f" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-1e6d5f1 elementor-widget elementor-widget-heading" data-id="1e6d5f1" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">PHARMACOVIGILANCE OPERATIONS <br>(End to End Pharmacovigilance Operations)</h1> </div> </div> <div class="elementor-element elementor-element-395ae00 e-flex e-con-boxed e-con e-child" data-id="395ae00" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-7c8e467 e-con-full e-flex e-con e-child" data-id="7c8e467" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-8874479 elementor-widget elementor-widget-heading" data-id="8874479" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">PHARMACOVIGILANCE SYSTEMS MASTER FILE (PSMF)</h1> </div> </div> <div class="elementor-element elementor-element-b2258a8 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="b2258a8" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text"> Preparation, Authoring and Maintenance of PSMF</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">The PSMF describes the MAH鈥檚 PV system and documents the compliance with the legal requirements in the EU/EEA</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">A PSMF must be kept fully up to date at all times. PSMF to be available within 7 days on-request for any National CA to inspect, that is why the day-to-day management, continuous updates, and expertise with handling PSMFs, is one of most critical aspects for all PV systems</span> </li> </ul> </div> </div> </div> <div class="elementor-element elementor-element-d9d2eb0 e-con-full e-flex e-con e-child" data-id="d9d2eb0" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-35bf940 elementor-widget elementor-widget-heading" data-id="35bf940" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">QPPV SERVICES</h1> </div> </div> <div class="elementor-element elementor-element-889dbcc elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="889dbcc" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">EU-QPPV/ QPPV Services</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Local Safety Officer (LSO) Services for India, EU, CIS Countries, MENA and LATAM</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Point of contact for Local Competent Authorities</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Local Regulatory Intelligence</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text"> Local Literature Monitoring</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Local Case Processing, Regulatory Submissions & Follow-up.</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Key Performance Indicators (KPIs)/ Compliance Monitoring</span> </li> </ul> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-4097c4a e-flex e-con-boxed e-con e-child" data-id="4097c4a" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-8265f5c e-con-full e-flex e-con e-child" data-id="8265f5c" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-c4f9900 elementor-widget elementor-widget-heading" data-id="c4f9900" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">ICSR PROCESSING</h1> </div> </div> <div class="elementor-element elementor-element-63ca444 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="63ca444" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">End to End Management of Case Processing</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">All Activities Starting from Case Triage, Data Entry, Quality Control, Coding, Medical Review, Reportability Assessment, Regulatory Submission, and Follow-Up</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Review of All Cases by Experienced Pharmacovigilance Physicians</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Ensuring Compliance Better than Industry Standards</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">High-Quality Narrative Writing</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">100% QC check</span> </li> </ul> </div> </div> </div> <div class="elementor-element elementor-element-941e7c6 e-con-full e-flex e-con e-child" data-id="941e7c6" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-13540dc elementor-widget elementor-widget-heading" data-id="13540dc" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">LITERATURE MONITORING</h1> </div> </div> <div class="elementor-element elementor-element-4bfc459 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="4bfc459" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Weekly/ Ongoing Literature Searching</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Identification, Triage & Processing of Literature Individual Case Safety Reports (ICSRs)</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Integration with Case Processing and 100% Reconciliation</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">PSUR Relevant Literature Search and Evaluation</span> </li> </ul> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-6b55566 e-flex e-con-boxed e-con e-child" data-id="6b55566" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-c312005 e-con-full e-flex e-con e-child" data-id="c312005" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-b2e8023 elementor-widget elementor-widget-heading" data-id="b2e8023" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">AGGREGATE REPORTS</h1> </div> </div> <div class="elementor-element elementor-element-3fb6dc9 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="3fb6dc9" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Complete Authoring and Production as per the Required Format of PBRERs/ PADERs/ PSURs/ DSURs/ASRs/ SBRs/ Addendums</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text"> Calendar Management and Planning of Aggregate Reports</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Compliance Monitoring</span> </li> </ul> </div> </div> </div> <div class="elementor-element elementor-element-751627f e-con-full e-flex e-con e-child" data-id="751627f" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-ef090b4 elementor-widget elementor-widget-heading" data-id="ef090b4" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">SIGNAL DETECTION & ANALYSIS</h1> </div> </div> <div class="elementor-element elementor-element-56bb099 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="56bb099" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Identification and prioritization of Signals</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Signal Evaluation through Individual Case Safety Reports (ICSRs) & Aggregate Reports</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text"> Regular Medical Monitoring of Safety Signals</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Complete Process of Signals including Signal Contextualization, Signal Evaluation, Literature Review for Epidemiological Inputs and Closing of Signal</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text"> Preparation of Signal Assessment Reports</span> </li> </ul> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-6f80e7f e-flex e-con-boxed e-con e-child" data-id="6f80e7f" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-64d5da2 e-con-full e-flex e-con e-child" data-id="64d5da2" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-43c2049 elementor-widget elementor-widget-heading" data-id="43c2049" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">RISK MANAGEMENT PLANS</h1> </div> </div> <div class="elementor-element elementor-element-8189534 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="8189534" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Complete Authoring and Production of Risk Management Plans</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Designing of Risk Minimization Measures (RMMs), including Websites, Educational Materials, Medication Guides etc</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Effectiveness Analysis for RMMs with the help of Surveys and Testing</span> </li> </ul> </div> </div> </div> <div class="elementor-element elementor-element-ee91085 e-con-full e-flex e-con e-child" data-id="ee91085" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-ad05858 elementor-widget elementor-widget-heading" data-id="ad05858" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">SAFETY DATA EXCHANGE AGREEMENTS (SDEAs)</h1> </div> </div> <div class="elementor-element elementor-element-453e040 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="453e040" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Preparation of SDEAs Customized per Country Specific Regulatory Requirements.</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text"> Review of SDEAs</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Set Up/ Fine Tune Processes to Ensure Compliance with SDEAs</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Reconciliations with SDEA Partners</span> </li> </ul> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-3ddaf83 e-flex e-con-boxed e-con e-child" data-id="3ddaf83" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-9a34a3c e-con-full e-flex e-con e-child" data-id="9a34a3c" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-e1e04a8 elementor-widget elementor-widget-heading" data-id="e1e04a8" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">QUALITY & COMPLIANCE</h1> </div> </div> <div class="elementor-element elementor-element-4985366 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="4985366" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Review and Manage Compliance Metrics for Key PV Activities</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Develop and Implement Quality Management System (QMS), including Preparation/ Review of SOPs and Work Practices</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Closure of Inspection Findings: Identify and Prioritize Improvements & CAPA Support</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Gap Analysis</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Good Pharmacovigilance Practices (GVP) Audits: Internal Audits, Self-Inspections, Vendor Audits, Partner Audits</span> </li> </ul> </div> </div> </div> <div class="elementor-element elementor-element-362aff6 e-con-full e-flex e-con e-child" data-id="362aff6" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-c677710 elementor-widget elementor-widget-heading" data-id="c677710" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">EXPERT SAFETY WRITING SERVICES</h1> </div> </div> <div class="elementor-element elementor-element-1c726dd elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="1c726dd" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Preparing Responses to Request for Information (RFI) from Competent Authorities</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">High Quality Narrative Writing</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text"> Preparing Direct Healthcare Professional (DHCP) Communications</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Analysis of Similar Events (AoSEs)</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Benefit Risk Assessment Reports</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Integrated Safety Summary (ISS)</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> <span class="elementor-icon-list-text">Safety Sections of Clinical Trial Reports</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-hand-point-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M512 199.652c0 23.625-20.65 43.826-44.8 43.826h-99.851c16.34 17.048 18.346 49.766-6.299 70.944 14.288 22.829 2.147 53.017-16.45 62.315C353.574 425.878 322.654 448 272 448c-2.746 0-13.276-.203-16-.195-61.971.168-76.894-31.065-123.731-38.315C120.596 407.683 112 397.599 112 385.786V214.261l.002-.001c.011-18.366 10.607-35.889 28.464-43.845 28.886-12.994 95.413-49.038 107.534-77.323 7.797-18.194 21.384-29.084 40-29.092 34.222-.014 57.752 35.098 44.119 66.908-3.583 8.359-8.312 16.67-14.153 24.918H467.2c23.45 0 44.8 20.543 44.8 43.826zM96 200v192c0 13.255-10.745 24-24 24H24c-13.255 0-24-10.745-24-24V200c0-13.255 10.745-24 24-24h48c13.255 0 24 10.745 24 24zM68 368c0-11.046-8.954-20-20-20s-20 8.954-20 20 8.954 20 20 20 20-8.954 20-20z"></path></svg> </span> 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