AXYS-NETWORK Consulting for aseptic processing
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1 AXYS-NETWORK
2 Axys-Network is a hands-on oriented pharmaceutical consulting firm, specifically involved with aseptic processing of injectable drug products. Axys Network is focusing on sterile drug products to assess risks, improve your performance and troubleshoot process issues. Our world-class experts provide turnkey modules which have already demonstrated their relevance in production sites. Further, we provide our clients with fully integrated consulting services, to support their strategic development projects Axys-Network has established a large network of world-class experts in the field of sterile and injectable drug products.
3 Our consulting model : the strength of an expert network The Axys-Network consultant world-class experts The Axys-Network back-office - to collect the network know-how Steering committee of experts for specific projects Strategic project management support For strategic project management support, our world-class experts and partners works as a multidisciplinary team offering a fully integrated consulting service.
4 Executive team & Back-office AXYS-NETWORK Eric Latour Manufacturing Alain Euzen QRM & QA Dr Monica Unger-Bady Regulatory Affairs Sylvie Guyomard Microbiology Alain Françon Biotech processes Didier Meyer PAT & Isolation technology Dr Jaime Guardiola Galenic development René Bommer Delivery Devices Jean-Jacques Chappaz Business development Jacques Navellou Business development
5 Manufacturing - Troubleshooting Support Auditing Mentoring -Training Risk assessment Sterile processing Technical transfer Lyophilization Compendial water Prefilled syringes Cytotoxics
6 Bio-processing - Troubleshooting Support Auditing Training Upstream processing Cell culture (static and biogenerators) Fermentation (bacteria and yeast) Lay-out and equipment Troubleshooting Process scale-up Training Services offered Process definition and validation master plan Process technology selection Equipment selection and URS definition Inactivated, live or recombinant vaccines Viral vectors Gene therapy Downstream processing Purification process Inactivation process Troubleshooting
7 Quality Risk Management & QA-QC - Troubleshooting Support Auditing Training GMP compliance & inspection readiness Inspection PAI (mock & support during inspection) Dealing with 483 s & warning letters Remediation plan Batch file & Release process API manufacturer audit VMP definition based upon ICH Q8 and review Changes-Deviations-CAPA management
8 Microbiology - Troubleshooting Support Auditing Training Standard methods expertise Integration of continuous improvement & compliance Alternative methods (RMM) Our implementation methodology in 5 steps
9 Regulatory affairs - Troubleshooting Support Auditing Training Regulatory compliance Regulatory strategy Regulatory submission Multiple change control management (Changes and submitted dossiers)
10 Process Analytical Technology (PAT) Axys Network initiate or customize your Process Analytical Technology (PAT) Support for PAT implementation Risk assessment for PAT integration Rapid Microbiology Methods Implementation & parametric release
11 Support services & Partners Interim Management Pharmaceutical Executive Search DBI - Demonstration batches ACM Pharma - Microbiology testing lab UPS - In-house Training Oxo-Consulting Kanupa - Financial advisory firm
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