GMP Consulting, Audits & Training
Structured consulting, audits, and training for regulated environments.
Pillar I: Strategic QMS Design & Baseline Architecture
This pillar establishes the foundation for any compliant system. Before documentation is created, the strategic direction and organizational structure must be clearly defined.
Initial Baseline Assessment: Conducting a focused on-site evaluation of production, quality control, and infrastructure from the perspective of an external auditor to establish an objective compliance baseline.
QMS Architecture Design: Defining the organizational setup and documentation hierarchy—whether paper-based, digital, or hybrid—to ensure a fit-for-purpose and lean framework before implementation begins.
Global Regulatory Roadmap: Identifying critical gaps and priorities against EU GMP, US FDA (USP), and Swissmedic requirements to provide a structured blueprint for the system build-up.
Pillar II: Global Inspection Readiness & Mock Audits
This pillar serves to validate and secure the system under realistic audit conditions, ensuring resilience against global regulatory scrutiny.
Mock Inspections: Realistic simulation of regulatory inspections to test the robustness of your systems and the decision-making capabilities of management prior to formal inspections by the FDA, Swissmedic, or EU authorities.
Management Alignment Sessions: Discussion-based sessions tailored to contextualize mandatory system elements and typical inspector expectations for organizations in the setup or maturation phase.
Audit Behavior & Coaching: Preparing management and key functions for technical discussions to ensure data is presented with regulatory confidence, transparency, and risk-based logic.
Pillar III: Independent Third-Party Audits
The third pillar focuses on the integrity of the global supply chain through neutral and expert assessments.
Supply Chain Integrity: Neutral assessment of global suppliers, contract manufacturers (CMOs), and service providers with a focus on risk, cross-jurisdictional compliance, and data integrity.
Comprehensive Audit Scope: Specialized audits according to GMP, GDP, and GACP standards for pharmaceutical operations, medical device manufacturers, and the medical cannabis sector.
Actionable Reporting: Each audit is concluded with a structured, objective report providing a realistic snapshot of compliance and prioritized recommendations for follow-up.
Professional Exchange
If you would like to discuss your current GMP status, audit readiness, or specific compliance topics, an initial professional exchange is possible.
