Quality
- Quality systems establishment and evaluation
- Quality systems revision/upgrade
- Risk assessment and developing quality risk management systems
- Risk management/planning
- Compliance assessment for GLP, GMP and GCP
- Pre-inspection readiness audits
- Preparation for pre-approval inspections (PAI)
- Establishing quality assurance and quality control functions
- Knowledge and application of standards e.g. ASTM and ISO
- Training
- Facility assessment
- Quality investigations
- Risk assessment and developing quality risk management systems
- Risk management/planning
- Product development reports
- Perform audits and inspections (US and global)
- Author Drug Master Files
- Develop Validation Master Plans
- Change control development (pre- and post-approval)
Caduceus Medical Development Ltd. offers a wide range of consulting services to Life Science companies
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