360biolabs, a BioAgilytix company, is Australia's most comprehensive bioanalytical lab, providing a comprehensive range of assay services for the development of new therapeutics, vaccines and diagnostics in a quality-assured environment. Located in Australia, the jurisdiction of choice for early phase clinical trials, we offer a diverse range of pharmacokinetic (PK) and pharmacodynamic (PD) endpoints including small molecule and large molecule PK, ADA, NAb, biomarkers (MSD, SIMOA, Luminex, ELISpot), molecular assays and virology, in a single laboratory for all your clinical trial requirements. Our global BioAgilytix team, with laboratories located in San Diego, Boston, Durham and Hamburg (Germany), can support your program from discovery DMPK through to Phase 4 clinical trials. We offer seamless transfer of assays from Phase 1 in Australia to our global labs for Phase 2 support. Our Quality Management Systems include internationally recognised accreditation (OECD GLP, GCLP, ISO/IEC17025) and our assay validation process and reporting is consistent with FDA and EMEA guidelines. The 360biolabs executive management team has more than 50 years combined industry experience. Our team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. 360biolabs is a trusted partner to many top global pharmaceutical and biotech companies. Our relentless dedication to accuracy, timeliness and regulatory rigor enables your therapeutic innovations to reach patients faster.