- Raw material sourcing
- Cost analysis
- FDA audit support
- Environmental permitting
- Analytical development
- Analytical validation
- Waste Water treatment piloting and evaluation
- Complete final product release testing
- Change control documentation and reporting
- Preparation of GMP compliant batch records
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- GMP API production
- Fermentation operations
- GMP warehouse facilities
- Microbial testing
- Process validation
- Pilot scale operations
- Process safety HAZOPs
- Process chemistry development
- On-site maintenance staff
- On-site engineers and chemists experienced in API
Manufacturing
- Foreign Trade Zone Status (FTZ)- reduced import taxes
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