GMP Audit
- Pre-regulatory inspections (WHO, USFDA, MHRA, EU GMP)
- GAP analysis in existing QMS
- Pre-certification inspections (ISO, FSMS, NSF)
GMP Training
- Good Manufacturing Practices
- Good Laboratory Practices
- ISO Documentation
- Process & Analytical Method Validation
Quality Management System
- Quality Assurance System
- Production System
- Laboratory Control System
- Material & Packaging Control System
Formulation Development
- Pre-formulation & compatibility studies
- Lab & pilot scale validation
- Stability studies
- Analytical method development
Custom Synthesis
- API & KSM development
- Reference standards & impurity characterization
- DMF / ANDA compilation
- Regulatory query response support