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Empowering Your Clinical Trial Regulatory Process

Navigating the Australian Clinical Trial Regulatory Process with Confidence

Guiding You Through Australia’s Clinical Trial Pathway with Confidence

NexaTrials Consulting delivers clear, accurate, and streamlined regulatory guidance for pharmaceutical companies, biotech firms, medical device developers, CROs, and academic researchers.


We support clients in navigating the Australian CTN/CTA pathway with confidence, accuracy, and professionalism — ensuring regulatory readiness at every stage.

CTN Submissions

Providing end-to-end support for the preparation and submission of Clinical Trial Notifications (CTN) to the TGA, ensuring accuracy, compliance, and streamlined approval.

HREC Ethics Coordination

Supporting the preparation, coordination, and submission of Human Research Ethics Committee (HREC) applications to ensure ethical compliance and smooth approval for clinical trials.

CTA Applications

Providing end-to-end CTA management, including dossier development, regulatory strategy, and submission coordination to support efficient TGA approval pathways.

Regulatory Documentation Review

Conducting comprehensive review and analysis of regulatory documentation to ensure accuracy, compliance, and alignment with Australian clinical trial requirements.

Expert Guidance. Streamlined Compliance.

With deep experience across the Australian clinical trial landscape, our team delivers strategic regulatory guidance and end-to-end submission support. From CTN and CTA applications to HREC coordination, we help you navigate complex requirements with precision, confidence, and reliable results.

Dedicated to Regulatory Excellence

5

Years of Experience

50+

Successful Submissions

100%

Compliance Rate

10+

Satisfied Clients

3

Industry Recognitions

Trusted Collaborations

Ready to Navigate the Regulatory Landscape?

Let NexaTrials Consulting be your strategic partner in achieving regulatory success. Contact us today to begin navigating CTN, CTA, and HREC requirements with confidence, clarity, and streamlined compliance.

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