A Clear Pathway From Korea to Global Development
Move through early development with speed and confidence, then scale into multi-regional and global programs. Korean biotechs approaching the move from preclinical development into the clinic can start with rapid first-in-human trials in Australia, build a high-quality early dataset, and then expand into North America and other key regions with aligned data and regulatory expectations. Avance Clinical’s integrated program oversight is designed to reduce operational complexity at each step.
Regulatory Pathways for Advanced Therapies in Australia
Advanced therapies need a regulatory partner who knows the way into the clinic. Avance Clinical’s in-house regulatory expertise has helped more than 700 biotechs approach Australia’s regulatory pathways in more than 250 therapeutic indications with confidence, shaping study design and global regulatory strategy so that early data is built for the markets that come next. With experience in submissions to regulators including Korea’s MFDS, Japan’s PMDA, and Singapore’s HSA, Avance Clinical keeps your program moving from the first regulatory question to the first patient.
First-in-Human in Australia, Supported From Seoul
Australia gives Korean biotechs a cost-efficient first dataset: R&D rebates of up to 43.5% on eligible spend, and early-phase data accepted by the TGA, FDA, EMA, and MHRA. With our Asia Hub in Seoul alongside, Korean sponsors have local support from the first conversation through the first dosing.
One Partner From First-in-Human to Global Scale
Through the GlobalReady program, biotechs work with a single CRO from first-in-human through later-phase, multi-country studies across Australia, Asia Pacific, North America, and Europe. This integrated approach is designed to maintain aligned processes and consistent data standards, so programs don’t rebuild relationships or processes at every border.
