
Regulatory Services
In-House Training Services
- Establishment and improvement of Quality Management System
- Establishment and improvement of Quality Control System
- Establishment and improvement of Production Management System
- Establishment and improvement of Material Management System
- Establishment and improvement of Facilities and Equipment Management System
- Establishment and improvement of Labeling and Packaging Management System
- Compile and review Validation Master Plan (VMP)
- Consulting on IQ, OQ, PQ and cleaning validation of facilities and equipment
- Consulting on process validation
- SOP, Checklist for GMP compliance
- Pre-inspection to the manufacture site before the on-site inspection of FDA, EDQM and other competent authorities
- Interpretation for on-site inspection of FDA, EDQM and other competent authorities
- In-house personnel training to ASM