TGA-Experienced CROs

Global leader in drug delivery technologies and development solutions. Catalent provides formulation, development, and manufacturing services for pharmaceuticals, biologics, and consumer health products.

Global leader in providing preclinical and clinical laboratory services. Charles River offers early-stage discovery, safety assessment, and clinical support services to pharmaceutical and biotech companies worldwide.

Global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. ICON specializes in clinical research with operations across 53 countries.

Formerly Covance, Labcorp Drug Development provides comprehensive drug development services from early discovery through post-approval. One of the world's largest CROs with extensive nonclinical and clinical capabilities.

A leading global contract research organization acquired by Thermo Fisher Scientific. PPD provides comprehensive clinical development services including laboratory, data management, and regulatory services.

Global biopharmaceutical services company providing clinical research, regulatory consulting, and market access services. Parexel has supported the development of many blockbuster drugs.

Hyderabad-based mid-size CRO operating across India, the Philippines, Thailand, Vietnam, and the Middle East, providing Phase I-IV clinical trial services and regulatory affairs.

Melbourne-founded CRO supporting small and mid-sized biotech companies across all clinical development stages including regulatory affairs, biometrics, and manufacturing scale-up.

Indian CRO providing Phase I BA/BE studies, bioanalytical testing, clinical pharmacology and early-phase research services with USFDA-inspected facilities in Navi Mumbai.

European CDMO with 13 production sites across seven countries providing oral solid dose, softgel, and sterile manufacturing for pharma and biotech clients.

Australian bioanalytical CRO providing GLP-compliant LC-MS/MS and ligand binding assay services for pharmacokinetic, bioequivalence, and immunogenicity studies supporting global regulatory submissions.

Full-service CRO purpose-built for small and mid-size biotech, combining legacy of CATO Research, SMS Oncology, Pharm-Olam, and Nuventra into an integrated clinical development partner.

Hyderabad-headquartered integrated CRDMO providing CRO and CDMO solutions for small and large molecules to 450+ global pharma and biotech clients with 3,000+ professionals.

Australian full-service CRO providing Phase 1–3 clinical trial management with expertise in biotech-focused programs. Known for the Australian Clinical Trial Notification (CTN) regulatory pathway advantage.

Leading large molecule bioanalytical CRO specializing in ligand-binding assays, immunogenicity testing, flow cytometry, and biomarker analysis for biologics drug development.

Indian biopharmaceutical company providing biosimilar development, contract manufacturing, and clinical research services with GMP manufacturing facilities for biologics and biosimilars.

South Korea's first CRO founded in 1997, providing comprehensive Phase I-IV clinical development solutions including regulatory affairs, data management, pharmacovigilance and medical translation.

Adelaide-based Phase 1 clinical pharmacology unit conducting first-in-human, bioequivalence, and biosimilar studies. Operates a 150-bed facility at the Royal Adelaide Hospital campus.

Full-service Australian CRO delivering clinical research services across Australia and New Zealand, supporting sponsors through Phase I-IV development.

Full-service mid-size CRO specialising in rare diseases, transplantation, nephrology, and immunology across Phase I-IV trials.

Global precision medicine CRO delivering biomarker and bioanalytical services including flow cytometry, histopathology, proteomics, and genomics for clinical trials.

Mid-size global CRO acquired by Labcorp providing clinical development services from Phase I through Phase IV with operations across Europe, Asia, and the Americas.

Global clinical trial technology and endpoint services company providing cardiac safety (ECG), respiratory, imaging, patient-reported outcomes, and clinical event adjudication for pharma and biotech sponsors.

Ahmedabad-founded full-service CRO and one of Asia's largest BA/BE and early-phase Phase I units, offering clinical, bioanalytical and biometric services across 4 countries.

Singapore-founded full-service CRO with operations across 12 Asia-Pacific markets, offering clinical trial management, regulatory affairs and data services.

Glasgow-founded, India-expanded full-service CRO providing clinical trial management, site management, and regulatory services across Asia-Pacific, Europe, and North America.

ISO 9001-certified full-service CRO with offices in Australia, Singapore, and India providing Phase I-IV trial management across the Asia-Pacific region.

Australian full-service CRO focused on early-phase clinical trials in oncology, rare disease, and dermatology, leveraging Australia's Clinical Trial Notification scheme for faster trial start-up.

Bangalore-based CRO subsidiary of Biocon offering early-phase clinical trials, bioequivalence studies, bioanalytical testing and Phase II-IV services with expertise in biosimilars.

Novotech's dedicated Phase I research unit in Sydney providing first-in-human, SAD/MAD, food effect, and bioavailability studies with a 30-bed clinical pharmacology facility.

Adelaide-based Australian Phase I clinical pharmacology unit within the Royal Adelaide Hospital, conducting first-in-human, BA/BE, and cardiac safety studies with a 48-bed facility.

Labcorp's early development and Phase 1 clinical unit operating dedicated clinical pharmacology facilities. Provides first-in-human, bioavailability/bioequivalence, and thorough QT studies.

Labcorp Drug Development's UK preclinical facility providing GLP toxicology, safety pharmacology, and reproductive toxicology studies from Harrogate, North Yorkshire.

Singapore-based global CRO consulting organisation assisting clients from clinical development through commercialisation with a focus on Asia-Pacific market access.

Australia's original full-service CRO since 1987, managing clinical research across all phases and most therapeutic areas for pharma, biotech and medical device companies.

South Korea's largest clinical CRO and Tigermed subsidiary, delivering full-scope clinical services with 1,200+ successful projects across pharmaceuticals, biotech, and medical devices.

Melbourne-based CRO specializing in Phase I-IIa first-in-human studies, offering rapid trial startup under Australia's CTN scheme with access to leading Australian clinical pharmacology units.

Global full-service CRO specializing in oncology, rare disease, and complex clinical trials across all development phases, with 2,900+ clinical research professionals operating in 100+ countries.

International group of laboratories providing testing and support services to the pharmaceutical, food, environmental, and consumer products industries. Major provider of bioanalytical and analytical testing services.

Global real-world evidence and outcomes research firm providing observational studies, health economics, market access, and regulatory evidence generation for pharma and biotech.

Contract research organization spun off from Labcorp in 2023. Provides Phase 1–4 clinical development services, patient access solutions, and regulatory consulting globally.

Asia-Pacific focused full-service CRO providing clinical trial management, data management, and biostatistics services with particular expertise in cardiovascular, renal, and diabetes trials.

Academic CRO based at Griffith University on the Gold Coast, conducting clinical trials in metabolic disease, sports medicine, and natural health products under TGA regulatory framework.

ICON's Australian operations leveraging Australia's CTN scheme for rapid Phase I trial initiation, supporting multinational sponsors with early-phase development in the APAC region.

Australian CDMO providing API manufacturing, sterile fill-finish, and pharmaceutical development services from TGA-licensed and FDA-registered facilities in Melbourne.

Global clinical research and health data analytics company formed from the merger of IMS Health and Quintiles. Offers end-to-end clinical development, real-world evidence, and technology solutions.

IQVIA's Japanese subsidiary providing clinical operations, real-world data analytics, regulatory strategy and technology solutions with one of the largest clinical operations teams in Japan.

Retina-specialty CRO with offices across Latin America, Asia, and Australia supporting clinical trials in 18+ countries for ophthalmic and rare disease indications.

Global testing and certification provider offering comprehensive pharmaceutical services including analytical testing, stability studies, extractables/leachables, and regulatory consulting.

Seoul-based full-service Korean CRO with 400 clinical trial experts and experience across 1,600+ studies including 180+ global multi-center trials.

Indian clinical CRO providing Phase I-IV clinical trials, bioanalytical services, and clinical pharmacology studies with dedicated Phase I units and bioanalytical laboratories.

Perth-based clinical trial site and CRO specializing in Phase 1–3 studies across multiple therapeutic areas. Located at the Harry Perkins Institute of Medical Research.

Japanese full-service CRO with global operations providing clinical development from early phase through post-marketing with deep oncology and CNS expertise across Asia, Europe, and the US.

Global CRO with nearly 1,000 employees covering 30+ countries, providing full-spectrum multilingual clinical development from early phase through post-approval in oncology and CNS.

Bangalore-based Indian CRO offering Phase I bioequivalence, bioanalytical and early-phase clinical research services for domestic and international generic pharmaceutical companies.

Australian not-for-profit pharmaceutical company developing and registering medicines for neglected tropical diseases, providing regulatory and clinical development services for global health products.

Australian boutique CRO specialising in early-phase and first-in-human MedTech clinical trials across Australia, New Zealand, and the USA.

Leading medical device CRO providing biocompatibility testing, sterilization validation, regulatory consulting, and clinical services for medical device and combination product development.

Asia-Pacific specialist CRO providing full-service clinical development capabilities with deep expertise in the Asia-Pacific regulatory landscape.

Greater China operations of Australian CRO Novotech, providing full-service clinical trial management across mainland China, Hong Kong and Taiwan with NMPA submission expertise.

Leading Australian Phase 1 clinical trials unit operating in Melbourne, Brisbane, and Minneapolis. Specializes in first-in-human, oncology Phase 1, and healthy volunteer studies with rapid enrollment timelines.

US arm of Australian CRO Nucleus Network, operating early phase clinical trials from their Minneapolis facility. Provides Phase 1 studies with access to diverse patient populations.

New Zealand's leading late-phase clinical research organisation delivering Phase III-IV trial results at speed and scale for global sponsors.

Independent New Zealand clinical research company conducting Phase I-IV trials with specialist early-phase capabilities and access to New Zealand's rapid ethics approval system.

Swiss full-service CRO operating in 56 countries with 3,000 staff, specializing in pivotal Phase II-III clinical trials in oncology, hematology, multiple sclerosis, and rare diseases.

Australian pharmaceutical research company providing preclinical and clinical development services with expertise in inflammatory bowel disease and gastrointestinal therapeutic areas.

Parexel's Japanese arm offering full-service clinical development, regulatory consulting and market access services with deep PMDA submission expertise.

Major global CDMO providing end-to-end pharmaceutical development and manufacturing services including drug substance, drug product, and commercial manufacturing under the Thermo Fisher Scientific umbrella.

Mid-size full-service global CRO offering Phase I-IV clinical trial management with strong coverage across emerging markets in Africa, Latin America, and Eastern Europe.

Global regulatory affairs and drug development consulting firm providing IND/NDA/MAA filing support, clinical development strategy, and pharmacovigilance services.

Australian CRO helping global pharma and biotech leverage the regulatory and cost advantages of clinical trials in Australia and New Zealand.

European regulatory affairs and pharmacovigilance services provider offering end-to-end regulatory strategy, submission management, and post-authorization compliance for pharma and biotech companies.

Specialty CRO focused on oncology and rare disease with 2,000+ professionals, known for biomarker-driven trial design, companion diagnostics, and translational research services.

Global regulatory consulting, pharmacovigilance, and clinical research organization providing single-source regulatory strategy, compliance, and medical information services.

Brisbane-based Phase 1 clinical trial unit specializing in first-in-human, pharmacokinetic, and vaccine studies. Operates a dedicated clinical pharmacology unit at QIMR Berghofer campus.

One of the world's largest data-focused biometrics CROs, providing biostatistics, statistical programming, clinical data management, and medical writing without conducting clinical operations.

Uppsala-based Swedish CDMO providing pharmaceutical development, manufacturing, and sterile fill-finish services with expertise in complex injectables and lyophilized products.

Specialist bioanalytical, biomarker, and analytical sciences CRO with 500+ experts providing FDA/EMA-inspection-ready regulated bioanalysis across the US, UK, and Australia.

National clinical research coordinating body in Singapore established by A*STAR and MOH, offering study design, project management, data management, and biostatistics to pharma and academic sponsors.

World's leading testing, inspection, and certification company. SGS provides pharmaceutical analytical services, clinical research, and regulatory compliance testing globally.

India's original CRO founded in 1996 providing clinical trial operations, FSP services, data management, medical writing, biostatistics and pharmacovigilance across global programs.

Sydney-based Phase 1 clinical pharmacology unit specializing in first-in-human studies, bioequivalence, and healthy volunteer trials. Part of the Novotech group.

ASX-listed Taiwanese CDMO providing world-class API synthesis, finished dose form manufacturing, and clinical packaging from GMP facilities in the Southern Taiwan Science Park.

Singapore's national academic clinical research organization supporting investigator-initiated and industry-sponsored clinical trials across Southeast Asia with strong oncology expertise.

Independent Australian full-service CRO specializing in pharmaceutical, medical device and biotechnology clinical trials, award-winning APAC CRO of the Year.

Hyderabad-headquartered pharmaceutical CRO with dedicated clinical trials division providing drug discovery, early-phase clinical, and regulatory support with strong CNS expertise.

Ahmedabad-based mid-size CRO providing Phase I-IV clinical trials, bioequivalence studies, and bioanalytical services to Indian and global generic pharma companies.

Integrated biopharmaceutical solutions company combining clinical development and commercial capabilities to accelerate customer success from Phase I through product launch.

China's largest independent CRO providing comprehensive clinical development services from preclinical through post-marketing with operations across China, Asia, and globally.

Ahmedabad-based CRO with a 350-bed Phase I clinical pharmacology unit, specializing in early-phase clinical trials, BA/BE studies, and bioanalytical services for global pharma clients.

Indian CRO providing Phase I clinical pharmacology, bioanalytical services, and bioequivalence studies from a 230-bed clinical pharmacology unit in Ahmedabad with USFDA and EMA track record.

Hyderabad-based publicly listed contract research and testing organisation offering integrated preclinical, clinical, and cGMP laboratory services for pharmaceutical companies worldwide.

Mid-size full-service global CRO offering integrated bioanalytical lab services alongside Phase I-IV clinical trial management with a focus on CNS, cardiovascular, and rare disease.

Global biologics CDMO providing end-to-end solutions for biologics drug development and manufacturing including monoclonal antibodies, bispecific antibodies, ADCs, and cell and gene therapies.

CRO purpose-built for first-in-human clinical trials for MedTech, biopharma, and radiopharma startups across Latin America, operating in 10 countries.

Physician-led Australian CRO offering full-spectrum clinical and non-clinical services with AI-driven operating model across Phase I-III for innovative biotechs.