QUALITY AND AUDITS
Quality evaluation
Process quality
- Risk analysis for the management of suppliers and subcontractors
- Optimization of processes and product flows
- Harmonization of multi-site practices
- Qualification of the equipment: from the elaboration of the protocol to the writing of the qualification report
- Setting up Lean management
Medical devices
- Support for the implementation of the quality system according to ISO 13485 standard
- Preparation of the certification audit by the notified body and inspections by competent authorities
Qualification and validation
- Policy development and validation strategy
- Design and realization of criticality analyzes
- Document architecture and validation
- Writing of all validation documents
- Supervision of tests, management of nonconformities
Audits
- Audits of API suppliers and pharmaceutical excipients
- Distributor audits
- Audits of pharmaceutical sub-contractors
- Suppliers of raw materials:
– validation of the Quality Control system
– audit of quality systems - Shared audits
- Audit of suppliers of cosmetic excipients
- Evaluation of cosmetic GMP processes
We support you throughout all steps of the conception and lifecycle of your products ensuring a complete quality service.
Thanks to our participation to international networks Regulanet and Pharmaxi, we have a privileged access to specialists in more than 90 countries.
STRATÉGIE SANTÉ
53, Boulevard de la Reine
78000 Versailles - France
Tél : +33 (0)1 42 86 86 00
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