List of Contract Research Companies in Australia - 9

360biolabs is Australia's most diverse bioanalytical and specialty laboratory offering science-driven expertise and laboratory services for Phase I-III clinical studies. Our advanced laboratories in Melbourne and Brisbane, specialise in using cutting-edge thinking and technology to support the development of novel therapeutics, vaccines and diagnostics. Our global team has laboratories in both the United States and Europe. With our every sample counts mindset, our meticulous attention to detail and adherence to global scientific standards under GLP, GCP and ISO17025 – ensuring the highest level of quality in every clinical trial we undertake. Our quality systems drive method development, tech transfer and assay validation, compliant with ICH, FDA and EMA. 360biolabs has an experienced team of scientists able to conduct a wide array of assays and offers diverse specialist services. Examples include: Pharmacokinetics (PK), Pharmacodynamics (PD), LC/MS, Flow Cytometry, Biomarkers, Molecular Assays, Virology, Central Laboratory services (kit production and lab manuals). __ Follow along in our journey enabling future medicines, or contact our team to learn more about our service offerings and get proposal estimates. Learn more at 360biolabs.com Get in touch via email at: bd@360biolabs.com

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Avania brings knowledgeable experts together to form a unique CRO that advances the research of medical devices, novel technology, and combination products across a wide range of therapeutic specialties. Our motivated team takes you from feasibility all the way through post-market trials. Our experts in data management and analytics, clinical trial design & execution, strategic consulting, regulatory, reimbursement, and more will provide you with customized, scalable solutions that optimize efficiencies and streamline the advancement of your medical technology. Your product is important, and your company deserves the team that has what it takes. It takes knowledge. It takes passion. It takes commitment. It takes Avania.

Crux Biolabs is an Australian bioanalytical laboratory specialising in PBMC processing, pharmacodynamics (biomarker, flow cytometry, ELISpot and ADA) and pharmacokinetics (large and small molecule) for clinical research. Our expert scientists can customise and validate a wide range of biomarker and cell assays in our ISO 17025 accredited lab in Melbourne, Australia. We also offer PBMC processing in Sydney with our dedicated satellite laboratory. We understand that each study is unique. That's why we take pride in becoming an extension of your team to deliver the best outcome for your studies. Crux Biolabs - where science leads.

Datapharm is Australia's original independent full-service Contract Research Organisation (CRO), est. 1987, providing clinical trial management, design, site set-up, monitoring, statistical services, data management (including eCRFs), medical writing, pharmacovigilance and auditing. Datapharm has earned an enviable reputation for quality, following involvement in hundreds of clinical trials in over 35 therapeutic areas, Phases I (including first-in-human) to IV, for Big Pharma, Biotech, Medical Device companies and Non-profit organisations. Datapharm works to ICH GCP and international regulatory authority standards with an overlay of excellent project management to achieve project milestones. Datapharm offers services internationally through the global CRO consortium DAI-SYS.

Formulytica is a specialty contract research, development and manufacturing organisation (CRDMO) with extensive expertise in formulation, analytical method development, and manufacture for a wide variety of topical and injectable dermatology, pharmaceutical, cosmetic and agricultural products. The laboratory is attached to a FDA, TGA and APVMA registered manufacturing plant that allow us to deliver unmatched product development and chemistry, manufacture and control (CMC) services including clinical and stability registration batch preparation. Formulytica is staffed with research scientists with an average 20 years' experience in the pharmaceutical industry, each now making their skills and experience available to other companies to develop or register new products.

Founded in 1975, IDT Australia is a publicly listed Australian pharmaceutical manufacturing company, based in Boronia Victoria. Our experienced and awarded team of scientists and specialists provide a flexible and comprehensive service, focussed in our three strategic pillars: Active Pharmaceutical Ingredient synthesis design, scale up and cGMP manufacture including high potent molecules Specialty Orals novel and early stage design, formulation and cGMP manufacturing specifically targeting neuro disorders Advanced Technology, complex formulations for novel injectable drug development through to cGMP manufacture. This pillar includes RNA and Antibody Drug Conjugates. IDT Australia also has a fully equipped laboratory approved to TGA and FDA standards to develop, validate and operate GLP analytics for release, process validation and stability. IDT Australia has labelling and packaging capacity and capability and specialises in clinical trial labelling and packing.

▶ WHAT WE DO: iNGENū CRO delivers FDA-compliant clinical trials for US Biotechs and saves them 70% of their clinical trial costs... WITHOUT the lengthy timelines typically associated with clinical trials. We manage all the heavy lifting to ensure that our clients can focus on what they do best – creating life-saving treatments. ▶ OUR FDA-EXCLUSIVE FOCUS: As a full-service CRO, our team members have the experience of hundreds of clinical trials behind them. Our unique, FDA-exclusive focus has created a CRO performing: 1. Clinical Trials (Phase I, II, and III) 2. IND-Enabling Non-Clinical Studies with Data in FDA-Compliant SEND Format 3. FDA Regulatory Submissions (PIND, IND, NDA) ▶ WHY WORK WITH US: 1. Government Grant Access: As an Australian CRO, all our clients (clinical and non-clinical) will receive up to 43.5% government R&D Incentive to perform their research with us. 2. Fast, High-Quality Research: We excel in conducting fast-paced research that strictly adheres to FDA guidelines and regulations. We ensure that our clients' timelines are met without sacrificing quality. 3. FDA Regulatory Expertise: With extensive experience in FDA regulatory work, we specialize in making full FDA pre-IND and IND submissions for our clients. 4. Diverse Therapeutic Specialty Leaders: Our team comprises physician and scientific specialists with expertise in a wide variety of therapeutic areas, enabling us to provide highly tailored solutions that meet the unique demands of your clinical trials. ▶ OUR TYPICAL CLIENT: An early-stage US biotech company who is looking for: • >70% cost reduction on FDA-compliant clinical and nonclinical trials • All data being 21 CFR 312.120 compliant for US FDA submission • Clinical trial startup time in 8-10 weeks • Commence FIH clinical trials prior to opening an IND • Perform rodent and second-species nonclinical studies at a fraction of the cost of the US ▶ READY TO TALK? ☎️ Like to find out more? Book a time to connect with us.

▶ WHAT WE DO: iNGENū CRO delivers FDA-compliant clinical trials for US Biotechs and saves them 70% of their clinical trial costs... WITHOUT the lengthy timelines typically associated with clinical trials. We manage all the heavy lifting to ensure that our clients can focus on what they do best – creating life-saving treatments. ▶ OUR FDA-EXCLUSIVE FOCUS: As a full-service CRO, our team members have the experience of hundreds of clinical trials behind them. Our unique, FDA-exclusive focus has created a CRO performing: 1. Clinical Trials (Phase I, II, and III) 2. IND-Enabling Non-Clinical Studies with Data in FDA-Compliant SEND Format 3. FDA Regulatory Submissions (PIND, IND, NDA) ▶ WHY WORK WITH US: 1. Government Grant Access: As an Australian CRO, all our clients (clinical and non-clinical) will receive up to 43.5% government R&D Incentive to perform their research with us. 2. Fast, High-Quality Research: We excel in conducting fast-paced research that strictly adheres to FDA guidelines and regulations. We ensure that our clients' timelines are met without sacrificing quality. 3. FDA Regulatory Expertise: With extensive experience in FDA regulatory work, we specialize in making full FDA pre-IND and IND submissions for our clients. 4. Diverse Therapeutic Specialty Leaders: Our team comprises physician and scientific specialists with expertise in a wide variety of therapeutic areas, enabling us to provide highly tailored solutions that meet the unique demands of your clinical trials. ▶ OUR TYPICAL CLIENT: An early-stage US biotech company who is looking for: • >70% cost reduction on FDA-compliant clinical and nonclinical trials • All data being 21 CFR 312.120 compliant for US FDA submission • Clinical trial startup time in 8-10 weeks • Commence FIH clinical trials prior to opening an IND • Perform rodent and second-species nonclinical studies at a fraction of the cost of the US ▶ READY TO TALK? ☎️ Like to find out more? Book a time to connect with us.