At Complete Phase, we deliver comprehensive clinical trial regulatory affairs services to accelerate approvals and ensure compliance across jurisdictions—from ethics applications through investigational drug importation and quality assurance.
As your dedicated clinical trial partner, we integrate ethics submissions, regulatory strategy development, import licensing, and audit-ready quality frameworks into an end-to-end regulatory affairs model. Our TGA expertise helps small U.S. sponsors anticipate key differences in the approval process between the U.S., Australia and New Zealand, and streamlines approvals for all sponsors.
Deep experience with HREC (Australia) processes ensures rapid ethics committee approvals. Our team will work closely with your sites, coordinating site submissions, informed consent documentation, and ongoing ethics reporting to keep your trial on schedule.
Our regulatory experts provide strategic advice on a range of regulatory pathways specific to your site and trial needs. We support you in preparing and submitting all required documents—protocols, investigator brochures, and regulatory summaries—to local regulatory authorities, anticipating agency feedback for efficient review.
We manage every step of investigational drug importation and customs clearance. Our team secures licences, handles customs documentation, and ensures temperature‑controlled logistics for uninterrupted supply.
Leveraging Good Clinical Practice (GCP)‑aligned QA frameworks, SOP development, and risk‑based oversight, we embed audit‑ready processes throughout feasibility, conduct, and close‑out. Regular quality audits and CAPA implementation maintain the highest standards of compliance and data integrity.
With expertise in all Australian TGA regulations, our Regulatory Affairs team guides small to medium biotech and pharma sponsors through known and novel regulatory requirements with speed, agility, and success. As your nimble clinical trial partner, we embed strategic foresight, proactive communication, and audit‑ready quality systems into every engagement—from first ethics submission to final approval.
Explore our other services—Clinical Operations, Medical Affairs, Biometrics, Pharmacovigilance, and more—and learn how we can help streamline your Phase 1 & Phase 2 clinical trials.
Ready to navigate Australian regulations with confidence?