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DISCOVER OUR SKILLS & COMPETENCES
Inspection preparation & Readiness
At each step of your preparation for inspection, you could ask for an extern support to:
1. Reinforce your intern preparation by advices and clear plan.
2. Train SME and collaborators to be ready to answers to inspectors
3. Provide personalised advices on your specific processes
4.Provide recommendations in presentation strategy and formulations answers.
Thanks to our consultants, request for an ex-FDA inspector to participate to a Mock Inspection (real simulation exercise).
1. Reinforce your intern preparation by advices and clear plan.
2. Train SME and collaborators to be ready to answers to inspectors
3. Provide personalised advices on your specific processes
4.Provide recommendations in presentation strategy and formulations answers.
Thanks to our consultants, request for an ex-FDA inspector to participate to a Mock Inspection (real simulation exercise).
Quality & Risk Management
At each step of your preparation for inspection, you could ask for an extern support to:
1. Reinforce your intern preparation by advices and clear plan
2. Train SME and collaborators to be ready to answers to inspectors
3. Provide personalised advices on your specific processes
4.Provide recommendations in presentation strategy and formulations answers.
Thanks to our consultants, request for an ex-FDA inspector to participate to a Mock Inspection (real simulation exercise).
1. Reinforce your intern preparation by advices and clear plan
2. Train SME and collaborators to be ready to answers to inspectors
3. Provide personalised advices on your specific processes
4.Provide recommendations in presentation strategy and formulations answers.
Thanks to our consultants, request for an ex-FDA inspector to participate to a Mock Inspection (real simulation exercise).
Qualification, Validation & Transfer Methodology
At each step of your product’s lifecycle, from initial development through commercialization, Validation program will ensure it is safe and effective.
1. Determine your needs and your validations'strategy
2. Dtermine your qualification's conditions and personalised assessment.
3. Design your strategy of requalifications
4. Evaluate rules to ensure a successful analytical transfer
1. Determine your needs and your validations'strategy
2. Dtermine your qualification's conditions and personalised assessment.
3. Design your strategy of requalifications
4. Evaluate rules to ensure a successful analytical transfer
QC, QA for QC , Scientific Expertise & Microbiology
For QC teams, we are focused on serving the comprehensive sense of all QC results, which is needed for treatment of deviations and release activities.
1. Clarify sense of each result and their specifications
2. Co-build a collective participation of all SME
3. Provide personalised advices on your specific processes
4. Improve and up-date SOP, documentations (chronologucal diagram..)
5. Organise work and improve workflow of operational activities
1. Clarify sense of each result and their specifications
2. Co-build a collective participation of all SME
3. Provide personalised advices on your specific processes
4. Improve and up-date SOP, documentations (chronologucal diagram..)
5. Organise work and improve workflow of operational activities
Continuous Improvements Strategy & Optimisation
At each step of your evolution of your organisation, processes must be adapted to be optimise to the situation that collaborators are living on the floor:
1. Identify your level of your organisation
2. Up-date each process to your level and design the vision of your futur
3. Provide personalised advices to generate global and continuous improvements strategy
4. Provide clear plan for each stratgey of improvements for each process
5. Organise with identified facilitators your team operational excellence
1. Identify your level of your organisation
2. Up-date each process to your level and design the vision of your futur
3. Provide personalised advices to generate global and continuous improvements strategy
4. Provide clear plan for each stratgey of improvements for each process
5. Organise with identified facilitators your team operational excellence
Microbiology Expertise GMP & non-GMP
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