Always on track
GLP Services
- Facility Audits
- Study audits
- Archive audits
- Process and system audits
- Standard Operating Procedures: preparation and review
- Establishing a QA program
- Mock inspections
- Study plan and report audit
- Document review
- Data and report audits
- Equipment validation
- GLP Training
- Regulatory Inspection Preparation
- Training for the performance of Multisite studies
CRO and Supplier Audits Services
- CRO, Subcontractor and Supplier audits in order to evaluate their compliance status
- Remote and onsite auditing of CROs, suppliers, vendors and animal breeders
GxP and ISO Services
- Inspection Readiness Support (Preparation for inspections by Monitoring Authorities or certification bodies (Mock Inspections)
- Developing and implementing of GXP compliant quality systems
- Developing and implementing of ISO (9001, 20000, 17025, 13485) quality systems
- Developing and implementing quality systems in non-regulated research areas
- Strategic guidance and oversight of Quality Systems
- Computer System Validation guidance and support
- Data Integrity Risk Assessment guidance and support
- Full QA services as external provider
- Review of all types of GXP-relevant documents
