Six principal practice areas, each delivered by the senior consultant. The practice serves as an extension of your regulatory team — accountable, technically rigorous, and direct.
Every engagement is scoped against the specific risk profile of your portfolio. We do not offer templated packages.
End-to-end management of ARTG listings, registrations, and variations for therapeutic goods entering the Australian market.
Compilation of technical and regulatory documentation aligned to current TGA, ICH, and IMDRF expectations.
Acting as your Australian sponsor under the Therapeutic Goods Act for overseas manufacturers and distributors.
Ongoing pharmacovigilance, surveillance, and incident management for products on the Australian market.
Compliance review for product labelling, packaging, permitted indications, and consumer-facing advertising material.
Quality management guidance and inspection readiness for sponsors, manufacturers, and contract sites.
Our clients range from ASX-listed medical device groups to early-stage sponsors seeking entry to the Australian market. The common thread is a preference for senior counsel that understands the regulator's current thinking and historical precedent.
Initial 30-minute consultations are complimentary. We will review your portfolio, classification matters, and provide a written quote within two business days.