Quality assurance, Quality Systems, GMP auditing, inspection readiness, deviation/CAPA management, validation, aseptic manufacturing, biologics, CGT, medical devices and facility readiness.
Enterprise Risk Management, ISO 22301-based business continuity management, business impact analysis, recovery planning, organizational resilience and Operational Excellence.
FDA GMP and QMSR requirements, ISO 13485, ISO 14971, EudraLex Volume 4 (EU Guidelines for Good Manufacturing Practice) and ISO 22301. Applicability is established per engagement.