• Construction & design / Redesign of SMQ – upgrading of SMQ
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– Risk management approach in the organization
– Deployment of GxP regulatory and quality requirements
– Implementation of processes, mapping of processes
– Drafting of quality documents
    • QMS maintenance
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– 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
    • Audits & Assessments
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– Internal/external audits
– System/procedures audits
– Inspections site preparation (FDA, ANSM ….)
    • Continuous improvement
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– Optimization of activities (lean management: formalization of objectives, evaluation of activities, highlighting of problems, identification of causes, problem solving)
    • Signal management
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– 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
    • Training, support for change
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– Establishment of training materials specific to needs (according to different standards)
    • Monitoring of regulatory and normative developments
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– Regulatory and normative monitoring
    • Deviation management and CAPA
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– Management of Change Control, deviations, non-conformities, CAPA
    • Risk Management
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– Assessment of quality risks
– Carrying out risk analysis based on pharmaceutical regulations and recognized guides.