Strategic QMS Architecture
&
Inspection Alignment
We architect inspection-ready frameworks that transition organizations from reactive remediation to sustainable internal ownership
An Inspection-Oriented Approach to System Stability
Our methodology is fundamentally defined by the perspective of an external auditor, assessing site operations and quality decision-making as they function in reality rather than relying on theoretical documentation reviews. By establishing an objective baseline through the eyes of a global inspector, we identify structural weaknesses and inconsistencies that are often overlooked in internally driven assessments. This approach ensures that every strategic recommendation is prioritised based on regulatory relevance and risk, allowing management to focus resources where they are most required for long-term stability.
Global Regulatory Strategy & Support.
Global QMS Architecture & Design
We provide site-specific blueprints for organizational setup and documentation hierarchy aligned with international regulatory expectations, including EU-GMP, US FDA (USP), and Swissmedic. This phase focuses on defining mandatory system elements and strategic direction prior to implementation, ensuring that the resulting QMS is fit-for-purpose and scalable across global operations.
Independent Third-Party Audits
Utilizing an auditor-centric perspective, we conduct neutral assessments of global suppliers and partners with a specific focus on cross-jurisdictional compliance and data integrity. Each audit is concluded with a structured, actionable report designed to support management-level decision-making and supply chain security.
Independent Advisor to Management.
As a Strategic Principal Consultant, my primary objective is to enable internal ownership of the Quality Management System rather than fostering dependency on consulting services. I act as an independent advisor to management, providing the high-level decision support and strategic system design necessary to ensure that the organization retains full accountability for its GMP compliance. My engagements are structured to facilitate a smooth knowledge transfer, ensuring that the system remains stable and compliant long after external support has concluded.
Transition to Sustainable Compliance
Establishing a GMP system that survives global regulatory scrutiny requires more than corrective actions; it requires a structured, step-by-step stabilization of your quality architecture. Whether you are at the initial stage of an EU GMP journey or preparing for a complex US FDA inspection, we provide the independent assessment and strategic blueprinting necessary to ensure long-term stability. Our engagements are designed to deliver immediate regulatory clarity while empowering your internal team to maintain full ownership of the system moving forward.
Contact
Mock Audits & Inspection Readiness
By simulating the scrutiny of major regulatory agencies, we test the robustness of your system and the preparedness of your management team. This realistic simulation identifies potential findings and compliance gaps, allowing for targeted remediation before a formal authority inspection takes place.
I invite management teams to initiate a strategic alignment discussion to define the scope, priorities, and regulatory roadmap for your site. Following our transparent commercial model, we provide fixed-fee proposals where possible that ensure full cost-certainty from the initial assessment through to the final strategy report.