QbD Group helps pharma and biotech manufacturers strengthen manufacturing performance through integrated quality, compliance, and operational expertise, keeping sites efficient, compliant, and inspection-ready.
Manufacturing environments are becoming more complex as regulatory expectations rise and advanced technologies are integrated into production. Sites must protect efficiency while remaining inspection-ready. This balance requires strong operational structure and quality oversight.
Without sufficient execution capacity and specialist expertise, organizations risk compliance gaps, operational strain, and delayed performance improvements.
Common challenges we see:
Compliance gaps as GMP expectations evolve and controls must remain risk-based and demonstrable in daily operations
Limited internal capacity to sustain qualification, remediation, and documentation activities over time
Gaps in specialist manufacturing and compliance expertise across disciplines
Pressure to improve efficiency while remaining compliant and inspection-ready
Difficulty resourcing complex, risk-based GMP requirements at operational scale
QbD Group’s Manufacturing Quality and Compliance solution connects compliance, execution capacity, and modernization into one coherent operational framework. Instead of reactive remediation, sites gain a structured path toward sustainable operational control.
We combine hands-on delivery with specialist expertise, helping manufacturing organizations embed regulatory expectations into practical, auditable daily operations. Support can scale with your operational reality, from targeted remediation to long-term lifecycle management.
Our approach is designed for sites that need immediate execution without losing sight of strategic improvement, enabling organizations to strengthen control today and build resilient manufacturing for tomorrow.
Build a clearer, risk-based line of sight from contamination risks to controls, evidence, and governance so inspections become easier to defend.
QbD combines integrated manufacturing capabilities with deep expertise, enabling organizations to work with one partner across their manufacturing compliance and operational needs.
We help manufacturing sites across the full operational lifecycle, from compliance strategy and remediation to sustained operational control and continuous improvement.
Our support spans quality, regulatory, validation, and digital domains, allowing coordinated delivery instead of fragmented vendors.
European expertise at scale while maintaining local responsiveness, ensuring complex manufacturing programs remain controlled, efficient, and inspection-ready.
