Expert regulatory support for clinical trials and marketing applications in Australia

Tricode Clinical provides TGA and OGTR expertise as your Local Sponsor or Regulatory Agent — delivering clarity, speed and compliant outcomes.

Regulatory Alignment

TGA Compliance

OGTR Framework

HREC & IBC Start-Up

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About Tricode Clinical

Tricode Clinical is a specialist regulatory consulting firm that can act as your Local Sponsor or Regulatory Agent in Australia. We combine deep, practical TGA and OGTR expertise with flexible, cost-effective execution across clinical research, gene technology, TGA marketing applications, and pharmaceutical product lifecycle management.

We exist to give international pharmaceutical, biotechnology, clinical research and medical device companies — a safe, reliable partner on the ground in Australia. Our team brings regulator-level knowledge, CRO operational experience, and real sponsor work. This means we understand what regulators expect, what sponsors fear, and how to close the gap efficiently without unnecessary overhead.

Our Services

Comprehensive regulatory support tailored to your needs

Clinical Trials

Clinical trial start-up support including site liaison, CTN preparation and HREC submissions
CTN and CTA submissions to the TGA
OGTR licensing (DNIR and DIR pathways)
IBC coordination and site compliance support
Local Sponsor or Regulatory Agent services

Marketing Applications & Lifecycle

ARTG inclusion applications
Regulatory strategy and gap analysis
Variations, renewals and lifecycle management
Post-market compliance support
Local Sponsor or Regulatory Agent services

Our Expertise

Deep, practical experience across the full regulatory landscape in Australia.

TGA Regulatory Affairs

Extensive experience with CTN, CTA, and marketing application submissions, including complex and novel products.

OGTR & Gene Technology

DNIR and DIR licence applications, IBC coordination, and ongoing site compliance monitoring for gene therapy trials.

Local Sponsor & Regulatory Agent

Flexible support models — acting as Local Sponsor or providing Regulatory Agent services to your Australian entity.

Why Australia?

Australia offers one of the most attractive environments globally for clinical research and product commercialisation — combining speed, quality, and significant financial incentives.

Fast regulatory pathways

The CTN scheme allows most trials to commence rapidly after HREC approval, often within weeks — far faster than many other jurisdictions.

Early human data for US sponsors

US-based companies can commence first-in-human clinical trials in Australia prior to finalising their IND submission with the FDA. This established pathway generates critical early clinical data that is accepted by the FDA. Tricode brings direct experience in global regulatory submission planning, helping clients strategically incorporate Australian early-phase studies into their broader development programs to accelerate timelines and strengthen subsequent FDA submissions.

Significant R&D Tax Incentives

Eligible sponsors can access Australia’s R&D Tax Incentive, offering a refundable tax offset of up to 43.5% on qualifying clinical trial expenditure. This is one of the most generous schemes in the world and can materially reduce net development costs.

High-quality research environment

World-class investigators, strong patient recruitment and retention rates, and a stable, English-speaking regulatory system with high data integrity standards.

Strategic Asia-Pacific gateway

Australia provides an excellent platform for broader regional development programs across Asia-Pacific, with recognised data accepted by major global regulators.

Clear and predictable framework

Transparent regulatory processes with well-defined requirements and experienced ethics committees that understand both local and international sponsor needs.

Free Regulatory Resources

Practical guides to help you navigate TGA and OGTR requirements in Australia.

TGA Clinical Trial Submission Checklist

A practical checklist covering CTN vs CTA pathways, required documents, HREC requirements, and common pitfalls to avoid.

Download PDF

OGTR Gene Therapy Quick Guide

Key requirements for clinical trials involving GMOs, including DNIR vs DIR pathways, IBC processes, and common pitfalls.

Download PDF

Local Sponsor vs Regulatory Agent Matrix

Clear comparison of the different models available to meet Australia’s Local Sponsor requirements, including pros and considerations.

Download PDF

Frequently Asked Questions

Common questions from international sponsors conducting clinical trials in Australia.

Yes. Tricode Clinical regularly supports US sponsors in running first-in-human and early-phase clinical trials in Australia while their IND is still in preparation or under review. We help design regulatory strategies that allow clients to generate valuable clinical data in Australia that can later strengthen their FDA submissions.

Yes. Tricode Clinical helps clients generate high-quality, regulatory-grade data in Australia that is accepted by the FDA. We work with sponsors to ensure Australian trial data is collected and documented in a way that supports future IND, NDA, and BLA submissions to the FDA.

No. Tricode Clinical can act as your Local Sponsor in Australia, taking on the legal and regulatory responsibilities required by the TGA and OGTR. This allows US companies to conduct trials in Australia without the cost and complexity of setting up a local corporate entity.

Tricode Clinical can advise US sponsors on structuring their Australian clinical trial activities to maximise eligibility for the R&D Tax Incentive. Eligible companies may access a refundable tax offset of up to 43.5% on qualifying expenditure, which can significantly reduce the net cost of running trials in Australia.

Tricode Clinical manages the full CTN submission process on behalf of clients. Once Human Research Ethics Committee (HREC) approval is obtained, we typically achieve TGA notification within 7 to 14 business days. We handle the preparation and submission to help clients start their trials as quickly as possible.

Tricode Clinical manages the full OGTR licence application process, including preparation, submission, and supporting clients through the evaluation phase. A Dealing Not Involving Intentional Release (DNIR) licence generally takes up to 90 days to process, while a Dealing Involving Intentional Release (DIR) licence typically takes between 150 to 170 days due to public consultation requirements. We also provide ongoing compliance support after licence approval to ensure continued adherence to licence conditions throughout the trial.

Tricode Clinical helps US sponsors navigate the differences between Australian HRECs and US IRBs. Australian HRECs are often more streamlined for multi-site trials and can have faster review timelines. We prepare submissions that meet Australian requirements while ensuring the data and documentation will also be suitable for US regulatory purposes.

Site activation in Australia usually takes longer than many US sponsors expect. After HREC approval and CTN notification, each site still needs to complete its own governance review, contract negotiations, and budget approvals. These processes can vary significantly between States and Territories and between public and private sites. Tricode Clinical actively manages site start-up activities, including contract and budget negotiations, to help minimise delays and coordinate activation across multiple sites as efficiently as possible.

Ready to Discuss Your Program?

Submit your details below. Our team will contact you within 24 business hours to arrange a strategy discussion.

Prefer to email us directly? info@tricodeclinical.com.au