Strategic Compliance for the Future of Medicine.
Emerging medical sectors offer immense potential but carry significant regulatory risk. We provide the technical and legislative blueprint for businesses entering the medicinal cannabis, weight management (GLP-1s), and performance medicine markets. From cultivation licenses to digital prescribing platforms, we ensure your venture is built on a foundation of total compliance.
01 | TGA & ODC Licensing (Cultivation, Manufacture & Supply)
Navigating the Office of Drug Control (ODC) and the Therapeutic Goods Administration (TGA) requires surgical precision. We manage the multi-layered applications required for the legal handling of controlled substances.
- Licensing & Permits: Managing applications for medicinal cannabis cultivation, production, and manufacturing licenses.
- GMP Certification: Ensuring your manufacturing facility meets PIC/S Guide to GMP standards for medicinal products.
- TGO 93 Compliance: Technical guidance to ensure all cannabis products meet the strict Australian quality and labeling standards.
02 | Telehealth Registration & SAS-B Pathways
For clinics and digital health platforms, the pathway to patient access is complex. We specialize in the regulatory architecture of “unapproved” therapeutic goods.
- Special Access Scheme (SAS): Implementing clinical workflows for SAS-B and Authorised Prescriber (AP) applications.
- Digital Clinic Setup: Building compliant telehealth protocols that meet AHPRA guidelines and state-specific prescribing laws.
- Clinical Governance: Developing the medical oversight and patient monitoring frameworks required for high-risk scheduled medicines.
03 | Wholesale & Import Registration
Scaling an emerging medicine business often requires international supply chains. We handle the technicalities of moving controlled substances across borders.
- Import/Export Permits: Managing ODC applications for each consignment of medicinal cannabis or other controlled scheduled drugs.
- Wholesale Licensing: Securing the necessary state-based Schedule 4 (S4) and Schedule 8 (S8) wholesale licenses to legally distribute products.
- Storage & Security: Advising on the high-level physical security requirements for the storage of controlled medicines (S8 vaults and restricted access).
04 | Clinic & Prescribing Platform Setup
Whether you are focusing on GLP-1 weight management, peptides, or cosmetic injectables, your digital infrastructure must be audit-proof.
Prescribing Compliance: Ensuring your platform prevents prohibited advertising of prescription-only medicines (TGA Advertising Code).
Software Integration: Guiding the setup of secure medical record systems that integrate with Medicare and the Australian Real-Time Prescription Monitoring (RTPM) systems.
Niche Sector Expertise: Specialized support for clinics in the Mental Health (Psychedelics) and Aesthetic sectors, focusing on emerging TGA clinical trial and prescribing frameworks.
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Your Time Can Change a Life.
From NDIS registration to clinical compliance, we provide the strategic roadmap your organization needs to thrive in regulated industries.