Welcome to the Australian Bio Directory

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186 Results found
Victoria

Adjutor Group

Australia
Adjutor Group, with Adjutor Healthcare and Adjutor Clinical sectors, is an Australia-based healthcare consultancy dedicated to fast‐tracking the development, registration, and commercialisation of innovative medicines and medical technology products across international markets. With a strong presence in Australia, New Zealand, and Hong Kong, and an established network of trusted partners worldwide, Adjutor provides clients with a single point of entry to major markets including Asia‐Pacific, North and Latin America, and the EU/UK.Founded on more than a decade of consulting experience, Adjutor combines deep regulatory, clinical, quality, and commercial expertise to support medicines, medical devices, combination products, and advanced therapies such as cell and gene therapies. The team has successfully supported the registration of hundreds of medicines and medical devices across all classes, guiding clients through complex regulatory pathways while optimising time, cost, and risk.Adjutor delivers end‐to‐end consultancy services spanning product development strategy, clinical development, regulatory affairs, quality management systems, training, sponsorship, and post‐market lifecycle management. Its regulatory services include gap analyses, dossier writing, submission management, regulatory agency interactions, GMP and ISO audits, and ongoing compliance support before and after approval. Through local legal entities, Adjutor can also act as product sponsor in selected markets, enabling efficient submissions and commercial supply.Clinical CRO services is provided across multiple regions, from early strategy and feasibility through to operational trial management, safety reporting, data analysis, and study reporting. Adjutor’s quality and training services help clients build robust, compliant systems that meet global standards and stand up to regulatory scrutiny.We operates as a true strategic partner rather than a traditional service provider. Adjutor works closely with innovators, biotech companies, and investors to overcome regulatory and commercial hurdles, support due diligence activities, and position products for long‐term success.By combining global reach with local expertise and a proven network, the Adjutor Group helps clients unlock global markets and confidently bring high‐quality healthcare products to patients worldwide. (more information: www.adjutor.com.au )
Advanced therapies including cell & gene
Clinical Trial Management and Support
Contact Research Organisation (CRO)
Industry Service Provider
Licensing/Technology Transfer
Medical Product
Medical Technology & Digital Health
Medicines
Therapeutics
Vaccines
Working with:
Contact person(s):
Languages
English
Year founded
2018
No of Employees
11-50
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Victoria

Excelligent Dx

Australia
Excelligent is an Australian spinout developing blood-based diagnostics for Alzheimer’s disease and related neurodegenerative disorders. Our platform captures extracellular vesicle miRNA biomarkers and combines qPCR testing with AI-enabled reporting to support earlier, more accessible, and scalable diagnosis. We are advancing an FDA-first, AD-focused pathway while building a broader brain-health platform for future multi-disease panels, OEM kit development, and strategic partnerships.
Medical Technology & Digital Health
Working with:
Contact person(s):
Year founded
2025
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Western Australia

Linear Clinical Research

Australia and 2 other(s)
Linear Clinical Research provides the most comprehensive clinical trial site capability in Australia, delivered across three specialist facilities, including the purpose-built Joondalup Early Phase Centre and Australia's first private hospital dedicated to cancer and other therapeutic trials, the Advanced Clinical Trial Centre.Leveraging rapid trial start-up and eSource technology, Linear delivers trials across all phases in healthy volunteers and patient groups, including next generation molecules such as RNA, bi/trispecifics and cell therapy. Having delivered over 500 trials since opening in 2010, Linear has developed innovative practices across volunteer recruitment, data capture, quality assurance and medical governance.As a profit-for-purpose company and subsidiary of the Harry Perkins Institute of Medical Research, Linear is solely invested in the success of your clinical program. We hold dedicated Medical Directors across our core portfolios of Phase I healthy volunteer, oncology, haematology, immunology and cardiometabolic, with capability extending across a broad range of therapeutic areas, enabling critical protocol optimisation and medical recommendations tailored to your programme.Australia offers a uniquely compelling environment for early-phase development. A fast regulatory framework removes the need for an IND application, an experienced and drug-naive volunteer population supports clean, high-quality data, and eligible pre-revenue biotechs benefit from a 43.5% R&D cashback incentive, making Australia one of the most cost-competitive destinations for first-in-human research globally.
Clinical Trial Management and Support
Company Type (Public/Private)
Contact Research Organisation (CRO)
Private
Research
Research Institute
Therapeutics
Working with:
Contact person(s):
Year founded
2010
No of Employees
260-300
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New South Wales

Obatica Oncology & Medical

Australia
Obatica Oncology & Medical is a boutique medical focused drug development and clinical trial consultancy firm based in Sydney Australia. Services includes clinical development and commercialization strategy, clinical trial study design, medical writing, medical director, medical monitor, and pharmacovigilance services.Obatica has been involved in over than 60 clinical trial projects with sponsors from US, Canada, Singapore, EU, and Australia.Specializing in complex early phase clinical trials in Oncology, Allergy, Pain and Rare diseases. Our development experience includes small molecules, monoclonal antibodies, RNA-based therapies, cell therapies and radiotheranostics.Our Medical Writing team can produce a high quality and faster than industry standard clinical trial related documents such as synopsis, Investigational Brochure’s (IB), protocol, PICF, CSR, and regulatory related submissions for instance INTERACT, IND, DSUR.Obatica is a leading Medical and clinical trial Functional Service Provider (FSP) providing cost effective fractional allocation of practicing clinicians with clinical trials experience, providing senior medical director or sponsor medical representative roles.Our in-house specialist doctors include Medical Oncologists, General Medicine Physicians, Geriatricians, and Surgeons to support your project. Let’s have a free initial confidential chat about your drug development or clinical trial project.
Clinical Trial Management and Support
Contact Research Organisation (CRO)
Working with:
Contact person(s):
Year founded
2021
No of Employees
5-10
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Queensland

Resolian Bioanalytics

Australia and 1 other(s)
Resolian is a global laboratory contract research organization that provides bioanalytical and analytical sciences support for drug development, preclinical, and multi-regional clinical trials, emphasizing exceptional solutions and strong collaborative relationships. The company offers services in drug metabolism and pharmacokinetics and bioanalytical, new drugs, metabolites or generic drug assays, large molecule immunoassays, small molecule metabolite profiling and identification and biosimilar characterization, thereby assisting clients through the process of taking a drug from pre-clinical trials to market at earliest.
Company Type (Public/Private)
Contact Research Organisation (CRO)
Research
Therapeutics
Working with:
Contact person(s):
Year founded
2007
No of Employees
20-600
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Queensland

Acclime Australia

Australia and 3 other(s)
Acclime Australia supports international companies, particularly foreign businesses, looking to establish and scale operations in Australia while accessing the benefits of the Australian Research & Development Tax Incentive program (R&DTI).Our team of corporate, tax, and R&D specialists assists international companies across a broad range of industries to enter the Australian market efficiently and compliantly, while taking advantage of generous benefits for innovation and technology development.Our services include:Market entry and corporate structuring advisory - Assisting companies in selecting the most appropriate structure for their Australian operations, including subsidiary incorporation, branch registration, and cross-border tax considerations.Australian company establishment and registrations – Managing the setup of Australian entities, tax registrations, and Australian bank account support to ensure a smooth market entry process.Resident Director and company officers – Providing experienced Australian/industry-based officers to satisfy local regulatory and tax residency requirements.R&D Tax Incentive advisory - Supporting companies throughout the full R&D lifecycle, including eligibility assessments, technical and financial documentation, application preparation, and ongoing compliance management.Transfer Pricing advisory – Assisting multinational groups with transfer pricing compliance and advisory services to ensure cross-border related party transactions are aligned with Australian tax regulations and transfer pricing principles.Ongoing accounting, tax, payroll, and compliance outsourcing –Enabling international companies to operate in Australia without the need to build a large internal administrative function.Registered office and operational support solutions – Allowing overseas businesses to maintain a compliant local presence while managing operations remotely.With local teams across Australia, the USA, UAE, and the Asia-Pacific region, Acclime combines international business expertise with practical on-the-ground support to help innovative companies confidently expand into Australia and successfully navigate their growth journey.
Company Type (Public/Private)
Industry Service Provider
Legal/Tax Specialists
Private
Working with:
Contact person(s):
Languages
EnglishSpanishFrenchChinese (Simplified)
Year founded
2011
No of Employees
1-2,000
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Victoria

Bioforum - The Data Masters

Israel and 3 other(s)
Bioforum is an international Biometrics focused CRO assisting companies to undertake clinical studies and collect, clean, integrate, and statistically analyse and report all data for submission to the US and European regulators, FDA and EMA, in compliance with regulatory data conventions (CDISC).We assist Sponsors engaging with the FDA for study design, project Optimus, data integration and study pooling strategies so that Bioforum's biostatisticians can prepare the mandatory Integrated Summaries of Safety and Efficacy (ISS/ISE).We prepare IBs, Protocols, EDC Databases, Tables/Listings/ Figures, Statistical Analyses, and Clinical Study Reports in close collaboration with the Sponsor’s representatives.We often act as the central data centre for pivotal phase 2 and 3 international studies so that the Sponsor can gain efficiencies in time and money through reuse of database components and analysis programs across studies while in parallel Bioforum prepares the integrated cross-study data repository required for preparing the ISS/ISE for submission to the FDA.We offer realtime project status access and clinical study data dashboards and analytics for Project Managers, Medical Monitors, Data Managers, Statisticians, DMCs, DMSBs, and other stakeholders via BioGRID.
Contact Research Organisation (CRO)
Working with:
Contact person(s):
Year founded
1997
No of Employees
200-250
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New South Wales

Celosia Therapeutics

Australia
Celosia Therapeutics is a clinical‑stage biotechnology company developing disease‑modifying therapies for neurodegenerative disorders with high unmet need.
Advanced therapies including cell & gene
Company Type (Public/Private)
Private
Therapeutics
Working with:
Contact person(s):
Languages
English
Year founded
2022
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Victoria

Central Pharmacy Logistics

Australia
CPL provides specialist logistics, depot, procurement, and manufacturing support services for clinical trials and life sciences organisations. The company enables efficient supply chain management for clinical studies, ensuring that investigational products and clinical supplies are handled, stored, packaged, and distributed in compliance with regulatory requirements.Its services include clinical trial supply logistics, comparator sourcing and procurement, labelling and packaging, temperature-controlled storage, global distribution, and depot management. CPL also supports manufacturing-related activities for clinical trial materials, helping ensure timely and reliable delivery of products to sites and patients worldwide.By combining operational expertise with a strong focus on quality and compliance, CPL helps sponsors and partners streamline complex supply chains and maintain continuity across global clinical studies.
Company Type (Public/Private)
Industry Service Provider
Private
Supply & Manufacturing
Therapeutics
Working with:
Contact person(s):
Year founded
2019
No of Employees
15-24
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New South Wales

Clinrol

Australia
Clinrol offers an innovative platform that connects patients with tailored clinical trials globally, serving as a comprehensive recruitment solution for sponsors, researchers, clinics, biotechs, and pharmaceutical companies.
Company Type (Public/Private)
Industry Service Provider
Medical Technology & Digital Health
Private
Recruitment
Software/Digital Health
Contact person(s):
Year founded
2020
No of Employees
15-20
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