Our tailored assay development, qualification, and validation are performed according to international regulatory FDA, EMA, ICH M10 guidelines, industry standards and project specific requirements.
For the most expeditious path into First in Human, Australia offers one of the fastest and most streamlined regulatory approval processes in the world with no IND requirement. Upon completion of nonclinical studies, biopharma can achieve clinical trial approval within 4-5 weeks.
Established since July 2011, The Australian Government’s generous Research and Development (R&D) Tax Incentive allows eligible biotechs can access up to 43.5% cash refund on R&D activities undertaken in Australia.