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 - includes coordinating MES/SCADA implementations, ISA-95 integrations, CSV validations, and multi-site rollouts with methodologies