Pharmalliance Consulting Ltd is supporting a European multi-product CDMO build their Contamination Control Program using the Contamination Control by Design (CCbD) methodology.

Pharmalliance helps pharmaceutical, medtech and cosmetics manufacturers achieve and sustain cGMP compliance across the full facility and product lifecycle. We combine deep expertise in contamination control, remediation, validation and quality systems to support clients through design, start-up, operations and regulatory inspections. We work across sterile, non-sterile, ATMP, oral solid dose and cosmetics environments. Our approach is practical, risk-based and aligned with EU GMP, FDA CFR and Annex 1 expectations. Our Services GMP Risk and Compliance Identify GMP, Annex 1 and contamination risks early. Strengthen compliance with structured assessments that prevent findings and delays. Design, CQV and Validation Strategic representation from concept through PQ. We ensure URS, design intent and qualification activities support inspection-ready facilities and processes. GMP Remediation Rapid support for sites facing compliance issues. We deliver action plans, onsite expertise and QMS improvements that restore stable, sustainable performance. Operational Readiness Prepare people, processes and documentation for compliant routine operation. We build strong QMS foundations and deliver CPD Certified training across QA, QC, Engineering and Operations. Contamination Control A pragmatic, risk-based approach aligned with Annex 1. Our CCS in 6 Weeks program provides a complete, audit-ready Contamination Control Strategy with proven tools and training. Regulatory Readiness and Product Launch Support for inspections, PAIs and regulatory submissions. We deliver mock audits, documentation readiness and coaching for confident inspection outcomes. Talent and Training CPD Certified GMP training that builds capability and compliance behaviours. Access experienced GMP professionals when additional expertise is required. Graduate Prep Program A structured pathway preparing new entrants for careers in life sciences.