Australia's Specialist in
Aseptic Fill-Finish
& Sterile Manufacturing
15+ years delivering Annex 1 compliance, CQV programs, and sterile manufacturing projects across Europe and Australia. I solve the problems that keep your QP awake at night.
Specialist Services
Focused exclusively on sterile manufacturing and aseptic fill-finish. Not a generalist. Not a staffing agency. A named expert with 15 years of hands-on delivery.
Aseptic Fill-Finish
End-to-end expertise in sterile vial, syringe, and cartridge filling. Isolator CCS design, PUPSIT, media fills, and contamination control strategies aligned with EU GMP Annex 1 (2022).
EU GMP Annex 1 Compliance
Gap assessments, CCS documentation, and remediation roadmaps for the 2022 Annex 1 revision. Practical implementation — not just gap reports.
CQV & Validation
Commissioning, Qualification, and Validation for sterile manufacturing equipment, utilities, and facilities. VMP to Summary Report, risk-based approach.
Greenfield & Brownfield Projects
Project leadership for new sterile manufacturing facilities and major upgrades. URS, DQ, IQ, OQ, PQ, and handover to operations.
Process Engineering
Sterile process development, technology transfer, and scale-up. Lyophilisation, liquid filling, WFI systems, and cleanroom HVAC design review.
Regulatory & Audit Support
TGA, FDA, EMA, and ANVISA inspection readiness. Mock audits, CAPA management, and regulatory submission support for sterile products.
Gregor Gantar
Principal Process Engineer · Aseptic Fill-Finish SME · APG Pharm
I am a Principal Process Engineer with over 15 years of hands-on experience in sterile pharmaceutical manufacturing. My career spans Slovenia, Switzerland, and Australia — working with global leaders including Sandoz/Lek, Novartis TechOps, Lonza, SKAN AG, and CSL Behring.
My specialisation is aseptic fill-finish: isolator qualification, contamination control strategy, CQV program leadership, and regulatory compliance across TGA, EMA, FDA, and ANVISA. I have authored CCS documents from scratch, led complex capital projects, and delivered over €1M in process improvements.
I founded APG Pharm to bring this depth of expertise directly to Australian and European manufacturers who need a named specialist — not a staffing agency — to solve their most complex sterile manufacturing challenges.
15 Years of Delivery
Process Engineer
Sterile manufacturing process development and validation for injectable products.
Senior Process Engineer
Led CQV programs for aseptic fill-finish lines. Annex 1 compliance projects, isolator qualification, and process improvements delivering €1M+ in savings.
CQV Consultant
Delivered CQV for sterile API and drug product manufacturing facilities.
Validation Consultant
Isolator and RABS qualification specialist for sterile fill-finish equipment.
Process Engineering Consultant
Pharmaceutical engineering consulting for sterile manufacturing projects.
Principal Process Engineer
Lead engineer on BACE II — a major aseptic fill-finish capital project. Annex 1 CCS authorship, isolator qualification, and cross-functional project leadership.
Let's Talk About
Your Project
I respond to all enquiries within 4 hours during business hours. For urgent matters, WhatsApp is the fastest route.