IDT Australia Limited What sets IDT apart is our ability to combine a cross-functional understanding of the challenges of drug development with the application of our world-class  R&D, manufacturing and clinical trial facilities and processes to accomplish your project on time, within budget and to the highest global quality standards.   Whether it is API synthesis, finished dose product manufacturing, analytical testing, clinical packaging or a first in man clinical study, IDT can tailor a flexible and responsive approach to suit your individual project’s needs.   IDT Pharma specialises in the development, scale-up, and cGMP clinical and commercial manufacture of high potency and cytotoxic API and finished drug product, with extensive experience developing cytotoxic, anti-cancer drugs, anti-psychotics, antibiotics, beta lactams and controlled drugs. Our API facilities offer fully scalable processes from laboratory R&D to commercial scale using multistep chemical synthesis in both dedicated and flexible (ISO 8) manufacturing space.    Oral finished drug product such as powders, hard gelatin capsules and film coated tablets are manufactured from small R&D and clinical trial scale to commercial volumes in full containment suites and our dedicated beta lactam facility can produce tablets and sterile parenterals (lyophilisation) in vials.   Analytical method development, validation and testing of both API’s and finished dosage forms can also be conducted in containment laboratories to enable analysis of highly toxic or highly potent products along with stability testing under all ICH conditions.   IDT Australia offers a comprehensive range of specialist clinical trial labelling, packaging and dispensing services and can manufacture, under cGMP active and placebo clinical trial supplies in a variety of dosage forms, including tablets, capsules, suspensions, liquids, and ointments.  IDT CMAX offers a comprehensive range of services for the design, implementation and management of clinical studies, specialising in Phase I and participating in Phase II to IV as an investigative site.    As Australia’s first established and largest Phase I unit, we have over 20 years experience conducting clinical studies in healthy volunteers and specific patient groups. With over 10,000 registered volunteers, extensive experience across a broad range of studies and patient populations we can start your clinical trial quickly and with confidence. Our 50 bed Phase I unit is ideally located at the Royal Adelaide Hospital and includes a 24-bed remote ambulatory cardiac telemetry monitoring ward. We offer a comprehensive range of services from initial cost estimates and planning, ethics application, protocol development through clinical packaging to archiving and close out of the study.   Studies comply with the registration requirements of the FDA, Canadian HPB, EMEA and Japanese MHW, are conducted in compliance with the principles of ICH GCP and local regulatory requirements and are internally audited As IDT is a Registered Research Agency  with the Australian Industry Research and Development Board, clients may be eligible for a 45 Cents in the Dollar Cash Rebate or a 40% Tax Shield on eligible R&D activities undertaken by IDT.