TGA Authorised Prescriber Scheme · TGO 112 / 113

Clinical governance for
psychedelic-assisted therapy

The compliance platform for Australian psychiatrists prescribing psilocybin for treatment-resistant depression and MDMA for PTSD. Track 70+ governance requirements, your Schedule 8 register and adverse events across all 8 states and territories.

14-day free trial · No clinical patient data leaves your device · Built for the TGA AP scheme

pat-compliance / dashboard
Neuralis Psychiatry · NSWCleared to operate
94%
Governance
3
Active patients
0
Serious AEs
Authorised Prescriber
Facility & environment
Schedule 8 management
Documentation
Workforce & training
8 domains · 70+ requirements

Every governance domain the regulators expect

The full clinical governance model for an Australian PAT program, mapped to TGA, ODC, HREC and state authority requirements.

Domain 1

Authorised Prescriber

TGA AP approval, HREC endorsement, state authority, AHPRA registration, training and ODC import licence - tracked with evidence and renewals.

Domain 2

Facility & environment

Treatment-room standards, emergency equipment, S8 safe, monitoring, recovery area and advance-notice obligations.

Domain 3

Drug supply & Schedule 8

Supply chain, storage, safe specifications and reconciliation in line with TGO 112 / 113 and state poisons legislation.

Domain 4

Patient screening & selection

Treatment-resistance documentation, contraindications, drug-interaction checks and medical clearance before treatment begins.

Domain 5

Treatment session protocol

Preparation, dosing, monitoring and integration against your HREC-approved clinical treatment protocol.

Domain 6

Documentation & reporting

Clinical records, TGA 6-monthly reports, state data-collection forms and audit-ready exports.

Domain 7

Workforce & training

Therapy-dyad qualifications, CPD and competency requirements for everyone in the room.

Domain 8

Ethics, safety & patient rights

Informed consent, safety planning, adverse-event handling and patient-rights obligations.

Features

From AP approval to TGA report, in one place

Governance tracker

Work through 70+ requirements across 8 domains with status, evidence and a clear "cleared to operate" banner.

Patient pipeline

A 5-stage tracker - Screening, Washout, Cleared, In Treatment, Completed - so no patient slips between stages.

Drug-interaction & screening

Flags SSRIs, MAOIs and lithium with severity at registration, plus per-substance contraindications and washout timelines.

Schedule 8 drug register

Receipt, administration and destruction with two-person witness, batch and expiry tracking, running stock balance and alerts.

Outcome measures & trends

PHQ-9, PCL-5 and GAD-7 with scoring, severity bands and SVG trend charts tracking response over time.

Adverse-event reporting

15 event types in 4 categories with severity classification and TGA reporting flags for serious or critical events.

Alerts & reminders

TGA 6-monthly reports, AP renewals, batch expiry, follow-ups and washout completion - surfaced before they become failures.

Clinical AI advisor

Conversational Q&A across 9 clinical topics with governance suggestions and evidence lists - rule-based, no API key needed.

Audit-ready PDF reports

Generate TGA 6-monthly and compliance reports - governance score, patients, sessions, adverse events and outcomes - in one click.

How it works

Compliant from clinic registration onward

1

Register your clinic

Enter your prescriber, AHPRA, state and substances - and see your state-specific approval pathway instantly.

2

Complete governance

Work through 70+ requirements across 8 domains until you are cleared to operate.

3

Run treatment safely

Track patients, the S8 register, session checklists, outcomes and adverse events as you treat.

4

Report with confidence

Export audit-ready PDFs for TGA 6-monthly reports and state data collection.

Multi-state support

Built for every Australian jurisdiction

Full regulatory data for all 8 states and territories - approval pathways, legislation references and facility requirements, with an all-state comparison table.

NSW VIC QLD SA WA TAS NT ACT
Pricing

Plans for prescribers, clinics and organisations

Every plan starts with a 14-day free trial - no credit card required. We only ask for payment when your trial ends. Then it bills monthly in AUD. No free tier. Cancel anytime.

Single

1 Authorised Prescriber

A$250/mo

14-day free trial - no card required, then billed monthly

  • Full 8-domain governance tracker
  • Patient pipeline & session checklists
  • Schedule 8 register & adverse events
  • Clinical AI advisor & PDF reports

Enterprise

Whole organisation

A$2,000/mo

14-day free trial - no card required, then billed monthly

  • Everything in Clinic, plus:
  • Organisation-wide deployment
  • Onboarding & staff training
  • Priority support & custom integrations

Prices in AUD, excluding GST. 14-day free trial with no credit card - we only ask for payment when your trial ends. Then billed monthly. Cancel anytime.

FAQ

Questions, answered

Who is PAT Compliance for?

Australian psychiatrists and Authorised Prescribers delivering psychedelic-assisted therapy under the TGA AP scheme - psilocybin for treatment-resistant depression and MDMA for PTSD - plus the clinics, programs and hospital departments supporting them.

Which regulations does it track?

The federal TGA Authorised Prescriber scheme and ODC import requirements, quality standards TGO 112 (MDMA) and TGO 113 (Psilocybine), and the drugs-and-poisons legislation for all 8 states and territories - across 8 governance domains and 70+ requirements.

Is there a free trial?

Yes - every plan starts with a 14-day free trial, then bills monthly in AUD. There is no free tier, and you can cancel anytime with no lock-in.

Does it handle Schedule 8 record-keeping?

Yes. The S8 register tracks receipt, administration and destruction with two-person witness documentation, batch and expiry tracking, a running stock balance, and low-stock and expiry alerts, including state-specific safe specifications.

Where does my clinical data live?

Clinical and patient records are stored locally in your own browser. We only hold your account and subscription status, via Supabase and Stripe - we don't upload the contents of your patient records.

Is this medical or legal advice?

No. PAT Compliance is a clinical governance and compliance aid. It does not constitute medical, legal or regulatory advice - always verify requirements against current legislation, the TGA, your state health authority and your HREC.

Stand up a compliant PAT program

Start your 14-day free trial - then billed monthly, cancel anytime.