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Quality · 360biolabs
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<h4>About Us</h4> </div> </div> <div class="column-menu"> <div class="sub-menus-container"> <div class="column-sub-menu"> <h5>Our Story</h5> <ul id="menu-our-story" class="list-unformatted sub-nav"><li id="menu-item-37" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-37"><a href="https://www.360biolabs.com/our-history/">History</a></li> <li id="menu-item-36" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-36"><a href="https://www.360biolabs.com/our-approach/">Approach</a></li> <li id="menu-item-35" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-35"><a href="https://www.360biolabs.com/australian-advantage/">Australian Advantage</a></li> <li id="menu-item-34" class="menu-item menu-item-type-post_type menu-item-object-page current-menu-item page_item page-item-22 current_page_item menu-item-34"><a href="https://www.360biolabs.com/quality/" aria-current="page">Quality</a></li> </ul> </div> <div class="column-sub-menu"> <h5>Meet the Team</h5> <ul id="menu-meet-the-team" class="list-unformatted sub-nav"><li id="menu-item-39" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-39"><a href="https://www.360biolabs.com/executive-team/">Executive Team</a></li> <li id="menu-item-40" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-40"><a href="https://www.360biolabs.com/bioagilytix/">BioAgilytix Global Team</a></li> </ul> </div> <div class="column-sub-menu"> <h5>Locations</h5> <ul id="menu-locations" class="list-unformatted sub-nav"><li id="menu-item-45" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-45"><a href="https://www.360biolabs.com/australian-locations/">Australia</a></li> <li id="menu-item-159" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-159"><a href="https://www.360biolabs.com/global-locations/#united-states">United States</a></li> <li id="menu-item-160" class="menu-item 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menu-item-object-page menu-item-766"><a href="https://www.360biolabs.com/lc-ms/">LC-MS/MS</a></li> <li id="menu-item-106" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-106"><a href="https://www.360biolabs.com/molecular-assays/">Molecular Assays</a></li> </ul> <h5>Pharmacodynamics (PD)</h5> <ul id="menu-pharmacodynamics-pd" class="list-unformatted sub-nav"><li id="menu-item-107" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-107"><a href="https://www.360biolabs.com/pharmacodynamics/">Pharmacodynamics</a></li> <li id="menu-item-108" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-108"><a href="https://www.360biolabs.com/flow-cytometry/">Flow Cytometry</a></li> <li id="menu-item-109" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-109"><a href="https://www.360biolabs.com/molecular-assays/">Molecular Assays</a></li> </ul> </div> <div class="column-sub-menu"> <h5>Immunogenicity</h5> <ul id="menu-immunogenicity" class="list-unformatted sub-nav"><li id="menu-item-111" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-111"><a href="https://www.360biolabs.com/immunogenicity/">Immunogenicity</a></li> <li id="menu-item-769" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-769"><a href="https://www.360biolabs.com/immunogenicity/#ADAs">Anti-drug Antibodies (ADAs)</a></li> <li id="menu-item-770" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-770"><a href="https://www.360biolabs.com/immunogenicity/#NAbs">Neutralising鈥ˋntibodies (NAbs)</a></li> </ul> <h5>Biomarkers</h5> <ul id="menu-biomarkers" class="list-unformatted sub-nav"><li id="menu-item-113" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-113"><a href="https://www.360biolabs.com/biomarkers/">Biomarkers</a></li> </ul> </div> <div class="column-sub-menu"> <h5>Vaccines & Infectious Diseases</h5> <ul id="menu-virology" class="list-unformatted sub-nav"><li id="menu-item-118" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-118"><a href="https://www.360biolabs.com/vaccines-infectious-diseases/">Vaccines and Infectious Diseases</a></li> <li id="menu-item-530" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-530"><a href="https://www.360biolabs.com/vaccines-infectious-diseases/#virology">Virology</a></li> </ul> <h5>Central Lab Services</h5> <ul id="menu-central-lab-services" class="list-unformatted sub-nav"><li id="menu-item-120" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-120"><a href="https://www.360biolabs.com/central-lab-services/">Central Lab Services</a></li> <li id="menu-item-121" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-121"><a href="https://www.360biolabs.com/kit-production/">Kit Production</a></li> <li id="menu-item-122" class="menu-item menu-item-type-post_type menu-item-object-page 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https://www.360biolabs.com/wp-content/uploads/360biolabs_Ligand-Binding-Assay-1400x930.webp 1400w, https://www.360biolabs.com/wp-content/uploads/360biolabs_Ligand-Binding-Assay-768x510.webp 768w, https://www.360biolabs.com/wp-content/uploads/360biolabs_Ligand-Binding-Assay-1536x1020.webp 1536w, https://www.360biolabs.com/wp-content/uploads/360biolabs_Ligand-Binding-Assay.webp 1920w" sizes="(max-width: 600px) 100vw, 600px" /> </figure> </a> </div> </div> </div> </div> </div> </div> </li> <li class="has-children"> <a>News & Media</a> <div class="menu-section is-news-media"> <div class="container"> <div class="section-columns"> <div class="column-heading"> <div class="heading-container"> <h4> News<br> & Media </h4> </div> </div> <div class="column-menu"> <div class="sub-menus-container"> <div class="column-sub-menu"> <h5>News & Events</h5> <ul id="menu-news-events" class="list-unformatted sub-nav"><li id="menu-item-126" class="menu-item menu-item-type-post_type menu-item-object-page 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class="list-unformatted sub-nav"><li id="menu-item-131" class="is-external menu-item menu-item-type-custom menu-item-object-custom menu-item-131"><a target="_blank" rel="noopener" href="https://au.linkedin.com/company/360biolabs">LinkedIn</a></li> <li id="menu-item-132" class="is-external menu-item menu-item-type-custom menu-item-object-custom menu-item-132"><a target="_blank" rel="noopener" href="http://weixin.qq.com/r/0B1kYfjEeTAFKLwCb0hU">WeChat</a></li> </ul> </div> </div> </div> <div class="column-contextual"> <div class="article"> <div class="inner-container"> <h6>360biolabs Latest News</h6> <a href="https://www.360biolabs.com/latest-news/" target="_self" class="article hover-default"> <p>Catch up on our latest events, news, blogs and more...</p> <figure> <img width="600" height="400" src="https://www.360biolabs.com/wp-content/uploads/DSC09324-600x400.webp" class="attachment-medium size-medium" alt="360biolabs koala and sticker memorabilia for conferences and roadshows" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/DSC09324-600x400.webp 600w, https://www.360biolabs.com/wp-content/uploads/DSC09324-1400x934.webp 1400w, https://www.360biolabs.com/wp-content/uploads/DSC09324-768x512.webp 768w, https://www.360biolabs.com/wp-content/uploads/DSC09324-1536x1025.webp 1536w, https://www.360biolabs.com/wp-content/uploads/DSC09324.webp 1920w" sizes="(max-width: 600px) 100vw, 600px" /> </figure> </a> </div> </div> </div> </div> </div> </div> </li> <li> <a href="https://www.360biolabs.com/careers/">Careers</a> </li> </ul> <a href="https://www.360biolabs.com/contact/" class="button has-gradient button-contact"> <span>Connect With Us</span> </a> <button class="button-main-menu-close" id="button-main-menu-close"> <span aria-hidden="false">Close menu</span> </button> </nav> <div class="main-menu-overlay button-main-menu-close"></div> <div class="toolbox"> <button class="button-main-menu-open" id="button-main-menu-open"> <span aria-hidden="false">Open menu</span> </button> <a href="https://www.360biolabs.com/contact/" class="button has-gradient button-contact"> <span>Connect With Us</span> </a> </div> </div> </div> </div> </header> <main id="main-content"> <section class="content-block block-hero"> <div class="container"> <div class="columns flex-justify-md"> <div class="column-content" data-neruda-anim="fade-in" data-neruda-anim-duration="1s" data-neruda-anim-delay=".25s"> <div class="inner-padding"> <h1>Quality</h1> <h2>Globally Recognised Accreditation</h2> </div> </div> <div class="column-image"> <div class="image-container" data-neruda-anim="block-hero"> <figure class="image"> <img width="1400" height="933" src="https://www.360biolabs.com/wp-content/uploads/Bri_Lab_6741-1400x933.webp" class="attachment-large size-large" alt="Team of scientists working in a bioanalytical laboratory" decoding="async" fetchpriority="high" srcset="https://www.360biolabs.com/wp-content/uploads/Bri_Lab_6741-1400x933.webp 1400w, https://www.360biolabs.com/wp-content/uploads/Bri_Lab_6741-600x400.webp 600w, https://www.360biolabs.com/wp-content/uploads/Bri_Lab_6741-768x512.webp 768w, https://www.360biolabs.com/wp-content/uploads/Bri_Lab_6741-1536x1024.webp 1536w, https://www.360biolabs.com/wp-content/uploads/Bri_Lab_6741.webp 1920w" sizes="(max-width: 1400px) 100vw, 1400px" /> </figure> </div> </div> </div> </div> </section> <section class="content-block block-main-content has-cyan-fair-bg"> <div class="button-page-scroll-container"> <a href="#page-content" class="button-page-scroll"> <span aria-hidden="false">Scroll to page content</span> </a> </div> <a id="page-content"></a> <div class="container"> <div class="columns"> <div class="column column-heading"> <h2>360biolabs<br /> <strong>Commitment<br /> to Quality</strong></h2> </div> <div class="column column-content"> <p>At 360biolabs, our dedication to quality is unwavering. With a focus on precision and compliance with international quality benchmarks, our analytical testing services prioritise meticulous attention to detail. Our method development and validation procedures align with global scientific regulatory frameworks such as FDA, EMEA, and ICH, ensuring adherence to stringent standards.</p> <p> </p> <p class="section-action"> <a href="https://www.360biolabs.com/australian-advantage/" target="_self" class="button"> <span>Australian Advantage</span> </a> </p> </div> </div> </div> </section> <section class="content-block block-quality-regulation"> <div class="container"> <h2 class="is-centered">Regulatory bodies</h2> <div class="section-intro"> <p>360biolabs follows global scientific regulatory bodies such as NATA, ICH, OECD, EMA, FDA</p> </div> <ul class="list-unformatted logos-container"> <li> <a href="https://nata.com.au/" target="_blank" rel="noopener" class="logo-card"> <figure> <img width="362" height="173" src="https://www.360biolabs.com/wp-content/uploads/NATA-logo.png" class="attachment-medium size-medium" alt="NATA accredited organisation" decoding="async" /> </figure> </a> </li> <li> <a href="https://www.ich.org/" target="_blank" rel="noopener" class="logo-card"> <figure> <img width="348" height="118" src="https://www.360biolabs.com/wp-content/uploads/ICH-logo.png" class="attachment-medium size-medium" alt="ICH logo" decoding="async" /> </figure> </a> </li> <li> <a href="https://www.oecd.org/" target="_blank" rel="noopener" class="logo-card"> <figure> <img width="324" height="78" src="https://www.360biolabs.com/wp-content/uploads/OECD-logo.png" class="attachment-medium size-medium" alt="OECD logo" decoding="async" loading="lazy" /> </figure> </a> </li> <li> <a href="https://www.ema.europa.eu/" target="_blank" rel="noopener" class="logo-card"> <figure> <img width="600" height="96" src="https://www.360biolabs.com/wp-content/uploads/EMA-logo-600x96.png" class="attachment-medium size-medium" alt="EMA logo" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/EMA-logo-600x96.png 600w, https://www.360biolabs.com/wp-content/uploads/EMA-logo-768x123.png 768w, https://www.360biolabs.com/wp-content/uploads/EMA-logo.png 796w" sizes="(max-width: 600px) 100vw, 600px" /> </figure> </a> </li> <li> <a href="https://www.fda.gov/" target="_blank" rel="noopener" class="logo-card"> <figure> <img width="600" height="125" src="https://www.360biolabs.com/wp-content/uploads/FDA-logo-600x125.png" class="attachment-medium size-medium" alt="FDA logo" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/FDA-logo-600x125.png 600w, https://www.360biolabs.com/wp-content/uploads/FDA-logo-768x160.png 768w, https://www.360biolabs.com/wp-content/uploads/FDA-logo.png 800w" sizes="(max-width: 600px) 100vw, 600px" /> </figure> </a> </li> </ul> </div> </section> <section class="content-block block-quality-systems"> <div class="container"> <h2 class="is-centered">Quality Systems</h2> <div class="section-content"> <p>360biolabs is accredited by Australia鈥檚 National Association of Testing Authorities (NATA) for compliance with the requirements of Good Laboratory Practice (GLP), as well as Good Clinical Laboratory Practice (GCLP) and ISO/IEC 17025.</p> <p>NATA operates a cycle of accreditation with assessment visits conducted regularly for ongoing compliance.</p> <p>360biolabs implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing data.</p> </div> </div> </section> <section class="content-block block-quality-team"> <div class="container is-wide"> <div class="columns flex-justify-md"> <div class="column column-text"> <div class="section-content"> <h2>Our Team Delivers Excellence in Quality</h2> <p>Our quality team is responsible for providing an effective and efficient system and regulatory counsel for our operational units, addressing QA aspects related to our science, technologies, information, and services cohesively.</p> <p>Quality operates independently from these operational units and regularly performs quality review activities (e.g., process/facility inspections and vendor audits) to ensure compliance with appropriate regulatory regulations.</p> <div class="section-action"> <a href="https://www.360biolabs.com/our-approach/" target="_self" class="button"> <span>Our Approach</span> </a> </div> </div> </div> <div class="column column-image"> <div class="image-container"> <figure> <img width="1920" height="1280" src="https://www.360biolabs.com/wp-content/uploads/Flow-cytometry_9446.webp" class="attachment-full size-full" alt="Scientist working in a GCLP, GLP and ISO17035 Laboratory from a QA issued SOP to ensure the reproducibility and quality of data" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/Flow-cytometry_9446.webp 1920w, https://www.360biolabs.com/wp-content/uploads/Flow-cytometry_9446-600x400.webp 600w, https://www.360biolabs.com/wp-content/uploads/Flow-cytometry_9446-1400x933.webp 1400w, https://www.360biolabs.com/wp-content/uploads/Flow-cytometry_9446-768x512.webp 768w, https://www.360biolabs.com/wp-content/uploads/Flow-cytometry_9446-1536x1024.webp 1536w" sizes="(max-width: 1920px) 100vw, 1920px" /> </figure> <div class="shape"></div> </div> </div> </div> </div> </section> <section class="content-block block-quality-quote"> <div class="container"> <div class="quote-container has-cyan-fair-bg"> <figure class="quote"> <blockquote> <p>Our commitment to quality鈥攁long with our unrivalled scientific expertise and technologies鈥攁llows us to provide our partners with the confidence of the most accurate, precise, and comprehensive high-quality bioanalytical testing services鈥攚ith integral results that are delivered right on time and right the first time.</p> </blockquote> <figcaption class="has-image"> <div class="image"> <img width="600" height="490" src="https://www.360biolabs.com/wp-content/uploads/Alistair-Draffan-600x490.webp" class="attachment-medium size-medium" alt="Alistair Draffan's profile picture" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/Alistair-Draffan-600x490.webp 600w, https://www.360biolabs.com/wp-content/uploads/Alistair-Draffan-768x627.webp 768w, https://www.360biolabs.com/wp-content/uploads/Alistair-Draffan.webp 1200w" sizes="(max-width: 600px) 100vw, 600px" /> </div> <div class="by-line"> <h4>Alistair Draffan, PHD </h4> <div class="role"> President at 360biolabs </div> </div> </figcaption> </figure> </div> <div class="section-hero-image"> <figure> <img width="1920" height="1280" src="https://www.360biolabs.com/wp-content/uploads/DSC09191.webp" class="attachment-full size-full" alt="Sample management team receiving samples, accessioning into LIMS, storing in 24/7 temperature monitored facility. Integrity of every sample counts" decoding="async" loading="lazy" srcset="https://www.360biolabs.com/wp-content/uploads/DSC09191.webp 1920w, https://www.360biolabs.com/wp-content/uploads/DSC09191-600x400.webp 600w, https://www.360biolabs.com/wp-content/uploads/DSC09191-1400x933.webp 1400w, https://www.360biolabs.com/wp-content/uploads/DSC09191-768x512.webp 768w, https://www.360biolabs.com/wp-content/uploads/DSC09191-1536x1024.webp 1536w" sizes="(max-width: 1920px) 100vw, 1920px" /> </figure> </div> </div> </section> </main> <section class="block-footer-cta"> <div class="container is-default"> <div class="columns"> <div class="column-text"> <p>Enabling future medicine together. 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