Rise Above with the Down-Under Advantage
Partner with CompletePhase to accelerate your Phase 1/2 studies with Australia's strategic advantages: streamlined TGA regulatory pathways, competitive costs with R&D tax incentives up to 43.5%, and access to diverse patient populations in a robust healthcare system.
We support Phase 1 and 2 trials in Australia and New Zealand, providing seed-stage biotechs and growing innovators with the strategic insight and local expertise needed to advance their trials with confidence.
Get Your Free Strategic Consultation
Get Ahead with The Australian Advantage
4 Weeks to Launch
Australia's TGA provides one of the world's most efficient regulatory pathways for Phase 1/2 trials, with approvals typically granted within 4 weeks of submission.
R&D Tax Incentive up to 43.5%
Take advantage of Australia's generous R&D tax incentive and competitive operational costs compared to US and EU markets for significant savings.
Global Regulatory Acceptance
Australian clinical data is globally accepted by FDA, EMA, and other major regulatory authorities, ensuring seamless worldwide development paths.
FDA vs. TGA: Key Considerations for Our International Sponsors
Submission Pathways
FDA IND requires pre‑submission meetings and detailed safety data, while TGA allows CTN without prior agency review, speeding initial start‑up.
Timelines & Fees
FDA review timelines average 30 days post‑IND submission; TGA CTN notifications are acknowledged within 10 days, with lower application fees.
Import Licensing
FDA uses Investigational New Drug import authorizations; TGA mandates import permits for unapproved goods and licences for controlled substances.
Ethics Oversight
U.S. IRBs operate under FDA/45 CFR Part 46, while Australian HRECs adhere to the National Statement on Ethical Conduct, requiring site‑specific review in multi‑site studies.
This is a Hands-On Partnership, Not a Transactional Vendor
We don't just execute—we strategize, advise, and adapt with you. Our seasoned team becomes an extension of your development team, providing proactive guidance at every stage of your clinical journey.
- Direct access to senior leadership and decision-makers
- Proactive communication and real-time problem solving
- Flexible protocols that adapt to your evolving needs
- Strategic insights based on 20+ years of industry experience
Built for End-to-End Early-Phase Success
From protocol design to regulatory submission, patient recruitment to data management—we provide comprehensive support for your Phase 1/2 trials with the agility and expertise that seed-stage biotechs need.
Guiding Principles
Expertise
Led by highly seasoned industry leaders with 20+ years experience, we excel in executing successful clinical trials across multiple therapeutic areas with proven results.
Excellence
Operating as strategic partners, we prioritise client satisfaction through proactive communication, anticipating needs, and identifying growth opportunities for success.
Agility
As an agile team, we provide customised solutions tailored to client needs. We swiftly initiate projects, iterate efficiently, and deliver beyond expectations consistently.
CompletePhase Services At A Glance
| Service Area | Phase I | Phase II | Key Advantages |
|---|---|---|---|
| Regulatory Affairs | Streamlined approvals | ||
| Protocol Development | Customized, flexible design tailored to your needs | ||
| Site Selection & Management | Established network of proven, high-performing sites | ||
| Patient Recruitment | Diverse population access with strong retention rates | ||
| Clinical Monitoring | Real-time oversight with quality-focused approach | ||
| Pharmacovigilance | Comprehensive safety monitoring and DSUR reporting | ||
| Medical Writing | Expert regulatory submission and documentation |
Who We Work With
Our clients are biotech innovators from the US, EU, and APAC – often running their first or second clinical trial. They're lean teams who need a partner that understands the fast-moving, high-stakes nature of early development and offers tailored support, not a one-size-fits-all approach.
Contact UsReady to Get Started?
Let's discuss how Australia's advantages can accelerate your Phase 1/2 studies. Our team is standing by to provide strategic insights tailored to your specific therapeutic area and development timeline.
+61 2 9876 5432
info@completephase.com
Melbourne, Australia
