Our Services
- Root Cause Analysis
- Deviation/CAPA management
- Creating and overseeing KPIs
Areas of Input
- Environmental Monitoring
- Quality Control testing
- Specification Creation
- Lot Release
Compliance with Regulations
Topics of Expertise
- 21 CFR Part 210/211
- 21CFR Part 11
- 21CFR Part 4
- ISO13085
- ICH Q9 and Q10
Industries We Serve
Pharmaceutical
Medical Device
Cell Therapy
