Our Methodology
Our Approach
A proven methodology to support your pharmaceutical validation projects from start to finish
Découvrez notre méthodologie
Analysis & Scoping
We begin each mission with complete immersion in your environment. Our experts analyze your existing processes, identify regulatory constraints specific to your sector (GMP, FDA, EMA) and assess your qualification and validation needs. This critical phase allows us to define a precise scope and measurable objectives.
Strategy & Roadmap
Based on our initial analysis, we develop a custom validation strategy aligned with your operational constraints and quality requirements. Our risk-based approach optimizes resources while ensuring compliance. We define a clear roadmap with precise milestones and identified deliverables.
Execution & Monitoring
Our team deploys the defined strategy with rigor and professionalism. We ensure execution of qualification protocols (IQ/OQ/PQ), writing of associated documentation and coordination with all stakeholders. Weekly monitoring ensures deadline compliance and deliverable quality.
Continuous Improvement
Beyond simple validation, we support you in sustaining your systems. We establish qualified state maintenance processes, train your teams in best practices and set up monitoring indicators. Our goal: to make you autonomous while remaining available for future developments.
How We Work
On-site Intervention
A field presence is essential to grasp the reality of your operations. Our consultants integrate with your teams to identify the specifics of your production lines and flows.
Project Mode
We structure each intervention with a proven methodology. Detailed planning, responsibility matrix, and regular reviews ensure control over deadlines and budgets.
Multi-stakeholder Coordination
The success of a project relies on the fluidity of exchanges. We act as a central pivot to synchronize the expectations of Quality, Production, and external suppliers.
"No Deviation" Culture
Our "Right First Time" approach aims for operational excellence. Through meticulous preparation and proactive risk analysis, we avoid costly non-conformities.
Your Trusted Partner
We support you from start to finish in your validation projects. From initial analysis to continuous improvement, our team of experts is by your side to ensure the success of your initiatives.