A top-tier European pharmaceutical manufacturer facing mounting regulatory pressure and ageing inspection systems partnered with PEYMAN Consulting to rethink its quality infrastructure, unlock smarter CAPEX planning, and lay the foundation for Pharma 4.0.
— Service Area
Digital and AI Transformation
— Focus Area
Smart Manufacturing Enablement
AI-Driven Inspection Strategy
Data Integrity and Compliance Readiness
— CLIENT
- A European-based, multinational pharmaceutical manufacturer with multiple GMP-compliant sterile facilities, focused on expanding its injectable product lines across the EU and MENA regions.
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— Challange
The client was grappling with ageing in-line inspection systems, regulatory compliance risks under new EU GMP Annex 1 revisions, and rising maintenance costs. At the same time, CAPEX budgets were under scrutiny due to post-COVID market shifts. They needed a strategic roadmap to:
Decide when to upgrade vs. replace critical inspection assets
Prioritise digital and AI investments in line with Pharma 4.0
Build a cost-justified, future-proof quality infrastructure
— Approach
PEYMAN Consulting led a multi-phase engagement across digital strategy, CAPEX planning, and innovation mapping:
Baseline Assessment
Conducted a full L1–L5 inspection system audit across three EU manufacturing sites, mapping maturity, risk exposure, and upgrade potential.Innovation & Compliance Roadmap
Developed a 5-year roadmap aligning new AI-based visual inspection, MES/SCADA integration, and predictive maintenance capabilities with regulatory and operational needs.CAPEX Reallocation Strategy
Modelled ROI trade-offs between full system replacements vs. modular AI retrofits, enabling the client to save €3.2M over three years by re-prioritising spend.Stakeholder Workshops
Facilitated cross-functional sessions (Quality, Ops, IT, Finance) to align on a shared transformation vision and build internal buy-in for change.
— Expected Results
€3M+ CAPEX savings through strategic reallocation and modular upgrades
Improved regulatory readiness with Annex 1-compliant digital inspection workflows
Faster deviation resolution and reduced manual rework via AI-enhanced visual inspection
A clear roadmap to adopt Pharma 4.0 capabilities without disrupting validated production lines
If you’re navigating compliance pressure, ageing inspection infrastructure, or digital transformation uncertainty, let’s talk.
Whether it’s an early-stage advisory call or a full roadmap engagement, I’ll help you unlock smarter investment strategies that balance risk, innovation, and ROI.
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