We close GMP gaps with audit-focused SOP analysis, inspection-ready facility and equipment qualification, and TGA readiness proven at a live Phase 1 autologous CAR-T facility.
Direct, hands-on experience inside GMP-regulated facilities — not textbook theory.
Standards held consistent — whether an inspector is present or not.
Every engagement led personally by the specialist doing the work.
GMP & GDP Auditing
Independent GMP audits and end-to-end distribution and storage assessment.
Gap Analysis
See where your systems stand and what it takes to close the gaps.
Documentation
Audit-ready technical documents and procedures written for the floor.
Quality Agreements
Clear agreements that define responsibilities before problems arise.
Vendor Qualification
Risk-based supplier assessment for confidence in your supply chain.
Validation
Equipment, process, and system validation built to withstand scrutiny.
Our Services
GMP Auditing & Mock Inspections
Gap Analysis & Compliance Assessment
Validation & Qualification
Technical Documentation & SOP Writing
Our Compliance Pathway
Step 1 - Assess
Gap Assessment
Assess your systems against TGA & PIC/S GMP to see where you stand.
STEP 2 — Govern
Regulatory Alignment
Anchor every decision to recognised standards — never assumption or habit.
STEP 3 — Remediate
Root-Cause Resolution
STEP 4 — Document
Audit-Ready Records
Common GMP & Compliance Questions
Clear answers to the most frequent questions about GMP audits, TGA licensing, validation, and quality system compliance.
Good Manufacturing Practice ensures products are consistently produced to quality standards — protecting patients and meeting regulatory requirements.
It means meeting Australian regulatory standards — enabling licensing, market access, and demonstrating your systems are reliable.
A gap analysis compares your practices against PIC/S GMP and TGA requirements to show exactly where you stand.
We review your processes, records, and facilities — delivering clear findings and prioritised actions.
Ready to Talk?
Reach out today to discuss your GMP compliance or TGA licensing needs.
Have any Question?
+61 469 033 063