What We Deliver
Specialist pharmaceutical consulting across the full sterile manufacturing lifecycle — from Annex 1 compliance to commercial fill-finish operations.
Aseptic Fill-Finish Consulting
Comprehensive support for vial, pre-filled syringe, and cartridge filling operations. Our team has direct hands-on experience with isolator technology, RABS, and conventional filling lines.
Enquire About This ServiceWhat's included
- Filling line design review and optimisation
- Aseptic process validation (APV) support
- Media fill programme development
- Technology transfer and scale-up
- Yield improvement and loss reduction
Annex 1 & Contamination Control Strategy
Full CCS development and implementation aligned with EU GMP Annex 1 (2023 revision). We have delivered CCS programmes for major European and Australian sterile sites.
Enquire About This ServiceWhat's included
- CCS gap analysis against Annex 1 (2023)
- Risk-based contamination control framework
- Environmental monitoring programme design
- Personnel qualification and training
- Regulatory submission support
CQV Programme Management
End-to-end commissioning, qualification, and validation for sterile manufacturing equipment, utilities, and facilities — from URS through to PQ.
Enquire About This ServiceWhat's included
- CQV master plan development
- IQ, OQ, PQ protocol writing and execution
- Equipment qualification (autoclaves, lyophilisers, isolators)
- Utility qualification (WFI, clean steam, HVAC)
- CSV and computerised system validation
Process Engineering & Optimisation
Lean Six Sigma-driven process improvement programmes that reduce waste, improve yield, and enhance operational efficiency across sterile manufacturing.
Enquire About This ServiceWhat's included
- Process capability analysis and improvement
- Lean Six Sigma Green Belt methodology
- OEE improvement programmes
- Root cause analysis and CAPA
- Batch record review and optimisation
Regulatory Compliance
Expert guidance on TGA, FDA, EMA, ANVISA, and ICH Q10 compliance — from pre-inspection readiness through to remediation planning.
Enquire About This ServiceWhat's included
- TGA and FDA inspection readiness
- GMP gap assessments
- Regulatory strategy and submission support
- CAPA programme management
- Quality system development
Sterile Manufacturing Operations
Operational excellence support for sterile drug product manufacturing — facility design, technology transfer, and ongoing operational improvement.
Enquire About This ServiceWhat's included
- Sterile facility design review
- Technology transfer management
- Cleanroom classification and qualification
- Gowning and aseptic technique training
- Operational readiness assessments
Engagement Models
Flexible options to suit your project and budget.
Day Rate Consulting
Flexible day-rate engagements for short-term technical support, audits, or advisory work.
Fixed-Price Projects
Defined scope, fixed price. Ideal for CCS development, CQV programmes, or gap assessments.
Embedded Consulting
Long-term embedded engagement with your team — available full-time or part-time.
Payment terms: Net 30 days (Net 60 available for established clients)
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