Compliance & Quality

We can step into QA leadership roles on an interim basis – whether to drive change, stabilize operations, or lead a critical improvement project.

Be prepared for IGJ, FDA or other authority or client audits. We offer mock inspections, document review, and direct support during or after regulatory visits.

Strengthening your CAPA System for lasting impact: We bring structure and clarity to your CAPA and deviation processes, supporting timely closure, root cause analysis, and sustainable corrective actions.

From small process changes to larger quality initiatives, we manage change control and related projects with a strong understanding of GMP and how things work in practice.

We assess your systems, data flows, and documentation practices against ALCOA+ principles to strengthen compliance and reduce data-related risks.

From Assessment to Action: Improving Compliance and Efficiency: We evaluate your quality systems to identify gaps, risks, and improvement opportunities – helping you to set priorities and implement meaningful upgrades.

We help you implement and maintain robust quality systems that meet all applicable GMP and GDP requirements. Whether preparing for audits or improving daily operations, we ensure your quality practices are inspection-ready.

As certified Qualified Person, we take responsibility for the EU-compliant release of your products, ensuring batch records, deviations and supply chain elements are all properly assessed.