Audit & Inspection Readiness

We support pharmaceutical, biotechnology, Life Sciences and healthcare organisations in assessing, strengthening and maintaining their state of GMP compliance through risk-based audits, mock inspections, gap assessments and tailored inspection-readiness programmes. Our approach is based on applicable EU GMP and international GxP requirements and considers the expectations of major regulatory authorities, including Swissmedic, EMA and FDA. We help organisations identify compliance gaps, evaluate regulatory risks and translate audit findings into practical, prioritised and sustainable improvement actions. Our audit expertise covers a broad range of organisations and activities across the pharmaceutical and healthcare value chain, including drug substance (DS) and active pharmaceutical ingredient (API) manufacturers, drug product and finished dosage form manufacturers, sterile and aseptic manufacturing facilities, biotechnology companies, ATMP organisations, CMO/CDMOs, contract laboratories, hospitals and hospital pharmacies, pharmaceutical distributors and logistics providers, packaging material suppliers, and manufacturers or suppliers of pharmaceutical equipment and critical systems. We also act as an independent audit partner when our clients need to qualify or periodically assess suppliers and outsourced activities. This includes audits of API and raw-material manufacturers, contract manufacturers, contract testing laboratories, packaging suppliers, equipment manufacturers and other critical service providers. Our assessments can therefore support both supplier qualification and oversight as well as the evaluation of organisations manufacturing, testing, storing or distributing products on behalf of our clients. Our team brings extensive experience across sterile manufacturing, final dosage forms, drug substance manufacturing and different pharmaceutical dosage forms and technologies, allowing us to adapt the audit scope and depth to the actual processes, products and risks of each organisation. But our audits go beyond a compliance checklist. We focus on understanding how the Pharmaceutical Quality System operates in practice, with particular attention to areas such as Quality Risk Management, CAPA, Change Control, deviations, supplier management, validation and qualification, contamination control, documentation practices and Data Integrity based on ALCOA+ principles. The objective is not simply to identify findings. We help our clients understand their regulatory exposure, prioritise remediation activities and strengthen their quality systems, building a sustainable state of inspection readiness.