About
NexaTrials Consulting supports sponsors across the Clinical Trial Approval (CTA) pathway by providing structured regulatory assistance aligned with TGA requirements. Our CTA support includes: - CTA pathway assessment and regulatory strategy - Preparation and review of CTA application dossiers - Scientific, technical, and safety documentation review - Protocol and supporting document review for regulatory alignment - Risk assessment support and regulatory gap analysis - Coordination with TGA interactions and regulatory queries (RFIs) - Regulatory compliance and readiness checks prior to submission We work closely with sponsors and research partners to ensure CTA applications are accurate, compliant, and aligned with Australian regulatory expectations.