AUDITS
With our partner
- 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
QUALITY EVALUATION
With our partner
- 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 & VALIDATION
With our partner
- 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
Pharmaceutical Development
