Independent Advisory · Project & CAPEX Support
Services
Independent, senior-level support for pharmaceutical manufacturers, equipment suppliers and technology partners—from early concept decisions through execution and operational readiness.
We operate based on strong ethical principles, technical integrity and a commitment to objective, value-driven guidance across the full project lifecycle.
Typical engagement points
Concept and technology selection · URS and design reviews · Vendor evaluation and FAT/SAT · CQV and operational readiness
We actively share knowledge, foster professional networks, and contribute to industry discussions through technical articles and advisory engagement in the following areas:
Core Advisory Areas
- Project Management Support
- Concept Development & Design Review
- Risk Assessment & Mitigation Strategies
- Project Planning & Execution Alignment
- Layout Optimization (Line & Cleanroom Concepts)
- URS Development & Review
- Qualification & Validation Strategy (CQV)
- Isolator Cycle Development & Validation
- Aseptic Process Definition (Cleaning, Transfer, Glove Integrity Testing, SOPs)
- Aseptic Fill & Finish System Strategy
Compliance & Quality
- EU GMP Annex 1 Interpretation & Implementation
- FAT / SAT Strategy, Execution & Open Point Management (OPL)
- Vendor & Equipment Selection
- Environmental Monitoring (EM) Strategy
- Batch Reporting & Alarm Management
Digitalization & Automation
- Industry 4.0 & Connected Manufacturing
- Predictive & Preventive Maintenance Concepts
- Automation & System Integration
- Data Integrity & Compliance (21 CFR Part 11, GAMP 5)
- Network Architecture & Cybersecurity Considerations
Business & Strategy
- Business Development Advisory
- Market Intelligence & Positioning
- Strategic Growth Support for OEMs & Suppliers