Regulatory clarity,
built by an operator.
Practitioner-led advisory for TGA, ODC and state-health licensing, quality systems and sponsor obligations — backed by a regulatory learning and controlled-document platform. From someone who has run a TGA-licensed, GMP-certified manufacturer.
Expertise, or infrastructure.
Engage Contxtyfy directly for a licensing project or ongoing advisory — or put the platform to work across your team so the knowledge and documents live in one controlled place.
Advisory & licensing
Hands-on, practitioner-led
Direct engagement for facility licensing, quality-system documentation, and sponsor obligations — scoped to your objective.
- Facility licensing & establishment (TGA, ODC, state health)
- SOPs, Substance & Site Risk Management Plans, CAPA
- Sponsor & therapeutic-goods consultation
- Retained regulatory advisory
The regulatory platform
Per seat · self-serve
A learning system, regulatory AI assistant, and controlled-document portal — the knowledge built into your team's day-to-day.
- LMS across TGA, ODC & Queensland Health regulation
- Regulatory AI assistant over a curated corpus
- Controlled-document portal — 30 base SOPs, SMP, SRMP
- NSW & VIC Health modules on the roadmap
Contxtyfy advises, prepares and documents. You retain regulatory accountability and approve and lodge all submissions and decisions. The platform is a tool — it provides regulatory information and document control, not regulatory or legal advice.
Four ways to engage directly.
Fixed-fee where the work is defined, day rate where it's open, retainer where it's ongoing.
Facility Licensing
Pathway mapping, gap assessment, dossier preparation, and inspection readiness across federal and state regimes.
Quality System Documentation
SOP development and remediation, Substance and Site Risk Management Plans, and CAPA system design.
Sponsor Consultation
Sponsorship obligations, product-quality oversight, labelling compliance, and materials review against the Advertising Code.
Retained Advisory
A standing regulatory capability — quality-system upkeep, horizon-scanning, and priority advisory access.
One platform,
three capabilities.
Learning, a regulatory AI assistant, and controlled-document management — all features bundled into a single per-seat price. Add jurisdiction modules as you need them.
Open the pricing calculatorPer month, billed annually, ex GST. TGA, ODC & QLD Health included. NSW/VIC modules from +$8/seat. Implementation from fixed-fee packages.
Built on time inside the framework.
Not theory — the lived discipline of operating a regulated manufacturer.
TGA-licensed, GMP-certified
Co-founder and former Managing Director of a medicinal cannabis manufacturer — inside GMP, ODC licensing, and Schedule 8 controls daily.
ALDI supply chain
An operations and supply-chain background where process rigour and documentation are non-negotiable.
MBA, University of Sydney
Strategic training applied to the commercial decisions behind every licensing and quality choice.
Find your context.
Whether it's a single licence, an ongoing retainer, or the platform across your team — start with an honest conversation about where you are.