About ITOT-Advice AG
Founded on Deep Industry Experience
ITOT-Advice is built on 24 years of hands-on pharmaceutical industry expertise, with the founder having spent two decades in a global leadership role shaping production strategies for a leading pharmaceutical group.
What Makes ITOT-Advice Unique
Insider Perspective
Unlike typical consultants who move between industries, ITOT-Advice brings an insider's understanding of pharmaceutical manufacturing - someone who has lived the challenges, understands the regulatory pressures, and has implemented solutions at scale.
Global Strategic Vision
With 20 years defining strategies for production sites worldwide, ITOT-Advice understands:
- How to harmonize systems across diverse geographic locations
- Regional regulatory differences and requirements
- Cultural and operational nuances of different sites
- Scalability from pilot to global rollout
Practical, Proven Solutions
ITOT-Advice doesn't offer theoretical frameworks - it provides battle-tested strategies that have been refined through decades of real-world implementation in highly regulated pharmaceutical environments.
Core Expertise Areas
1. IT/OT Integration
Bridging enterprise and operational systems
2. ISA-95 Implementation
Vertical integration strategies
3. CSV Compliance
Validation expertise across regulatory regions
4. Multi-site Strategy
Global production network optimization
5. Project Delivery
MES/SCADA implementations, ISA-95 integrations, CSV validations, and multi-site rollouts with proven methodologies