Regulatory Specialist Intelligence

Regulatory compliance built into every workflow.

Regulatory Specialist Intelligence handles the complex regulatory landscape of AU pharmacy practice. From TGA compliance and PBS authority processing to SAS pathways and state/territory poisons obligations, it keeps your practice aligned with current requirements.

Core capabilities

What Regulatory Specialist Intelligence does for you.

TGA Compliance Checks

Validates prescribing and dispensing against Therapeutic Goods Administration requirements, ensuring all products meet current scheduling and registration standards.

SAS & Unapproved Medicines Pathways

Streamlines TGA Special Access Scheme (Category A/B/C) submissions and Authorised Prescriber notifications for unapproved therapeutic goods, ensuring sourcing decisions meet current TGA conditions.

PBS Authority Processing

Streamlines Pharmaceutical Benefits Scheme authority approvals by verifying eligibility criteria, restriction codes, and streamlined authority conditions in real time.

Schedule Compliance

Monitors prescribing and dispensing against S2, S3, S4, and S8 scheduling — from Pharmacy Medicine and Pharmacist Only counselling obligations through to controlled drugs record-keeping under the Poisons Standard (SUSMP) and state/territory Drugs & Poisons Acts.

Regulatory Change Tracking

Stays current with regulatory updates from relevant authorities, alerting practitioners when changes to scheduling, PBS listings, or compliance requirements affect practice.

Audit Trail Generation

Produces comprehensive audit trails for regulatory inspections, documenting every compliance check and decision point for transparent review.

See Regulatory Specialist Intelligence in action.

Learn how this Specialist keeps your pharmacy practice aligned with TGA, PBS, and state/territory Poisons regulations without adding to your workload.