– Risk management approach in the organization
– Deployment of GxP regulatory and quality requirements
– Implementation of processes, mapping of processes
– Drafting of quality documents

– Continuity of the activities put in place: establishment of the quality plan
– Quality documentation management
– Management of quality systems and processes
– Update of quality documents

– Internal/external audits
– System/procedures audits
– Inspections site preparation (FDA, ANSM ….)

– Optimization of activities (lean management: formalization of objectives, evaluation of activities, highlighting of problems, identification of causes, problem solving)

– Qualitative (revision of ICSRs) and quantitative (statistical analysis in databases) detection of signals
– Validation and evaluation of signals identified during vigilance activities
– Definition of possible measures to minimize the risks associated with the signals
– Communicate immediately to the authorities the signals that may have repercussions on public health and the benefit-risk profile of the products in question

– Establishment of training materials specific to needs (according to different standards)

– Regulatory and normative monitoring

– Management of Change Control, deviations, non-conformities, CAPA

– Assessment of quality risks
– Carrying out risk analysis based on pharmaceutical regulations and recognized guides.