Automation & digitalisation
QMS digitalisation, data integrity, and process automation while maintaining GMP and regulatory compliance.
Projects
We support technology transfers, manufacturing optimisation, regulatory submissions (NDA, BLA), scale-up, and global compliance alignment. With 33+ years of combined experience, we deliver senior-led, regulation-ready execution.
Project Types We Support
From automation and digitalisation to quality, compliance, supply chain, and production optimisation, we support your pharma and biopharma objectives with an agile, risk-based approach.
Industry benchmarking
Benchmarks and maturity assessments to position your operations and quality systems against peers.
Performance & maturity diagnostic
Gap assessments across manufacturing, QC, raw materials, and traceability; clear remediation roadmaps.
Project & program management
Structured delivery of regulatory transformation, remediation, and multi-site programmes.
Quality & compliance
QMS implementation and maturity, contamination control, validation, and inspection readiness.
Technical operations & supply chain
Scale-up, tech transfer, and supply chain robustness from API to finished product.
Procurement & sourcing
Raw materials, DMFs, and supplier quality aligned with regulatory expectations.
Leadership development
Upskill leaders and teams to drive performance, quality culture, and sustainable change.
Production optimisation & industrialisation
From clinical to commercial scale: design, validate, and ramp up manufacturing efficiently.
Process rationalisation & efficiency
Streamline processes, reduce waste, and improve right-first-time outcomes.