EU-GMP-COMPLIANT & OPERATIONAL EXCELLENCE

From Blueprint to Certified Production

Delivering a certified pharmaceutical facility is a high-stakes endeavor where GMP compliance is non-negotiable. My end-to-end project methodology aligns complex regulatory standards with construction realities . Acting as your central project lead, I orchestrate the entire stakeholder landscape – coordinating architects, engineers, and QM experts – to reduce costly delays. My focus is a facility that is not just built, but delivered on time, on budget, and prepared for regulatory approval.

1. Feasibility & Regulatory Roadmap 2. Vendor Selection & Design Oversight 3. Construction & Pre-Audit 4. Operational Handover & Ramp-Up

Conducting feasibility studies and site analysis to validate the business case. Defining precise ‘User Requirement Specifications’ (URS) to set the regulatory foundation and guide the design phase.

Vetting and selecting specialized technology partners (cultivation and extraction). Actively overseeing the design phase so that facility layouts and workflows are built to meet GACP/GMP compliance standards.

Acting as the owner’s representative during construction. Coordinating external ‘Mock Audits’ to identify and close compliance gaps before the official authority inspection.

Managing the operational handover: Commissioning the facility, coordinating staff training and SOP finalisation, and guiding the structured start of commercial production.