MANUFACTURING PHARMACEUTICAL SERVICES
PRODUCT:
- API SOURCING
- EXCIPIENT SOURCING
- COMPONENT SOURCING
- VENDOR AUDITING AND QUALIFICATION
- PROCESS IMPROVEMENT
- PROCESS AUDITING
- 483/WARNING LETTER REMEDIAL ACTIVITIES
- STABILITY DESIGN, TESTING AND REPORTING
- SPECIFICATION DEVELOPMENT
- CMC SECTION WRITING
MANUFACTURING AND PACKAGING PROCESSES:
- MANUFACTURING SUPPLY AGREEMENTS
- QUALITY AGREEMENTS
- PROCESS QUALIFICATION-VALIDATION
- SCHEMATIC FACILITY DESIGN
- A&E QUALIFICATION REVIEW
- A&E CONTRACT NEGOTIATIONS
- QUALITY IMPROVEMENTS
- EQUIPMENT SELECTION, EQUIPMENT SOURCING, FAT SUPPORT, INSTALLATION, SAT SUPPORT AND
EQUIPMENT QUALIFICATIONS
- COMPONENT COMPATIBILITY AND STRESS TESTING
- SUPPLY CHAIN MANAGEMENT
PROJECT MANAGEMENT
- GANTT CHARTS - TIMELINES
- COST ESTIMATING
- MEETING COORDINATION AND FOLLOW-UP
- CONTRACT COMPLIANCE
- BUDGET CONTROL
QUALITY ASSURANCE
- VENDOR QUALIFICATION AND AUDITING
- FACILITY AUDITING
- REGULATORY RESPONSES AND REMEDIAL ACTIVITIES
- TECHNICAL WRITING
- SOP's
- BATCH RECORDS
- VALIDATION PROTOCOLS AND REPORTS
- TECH TRANSFER REPORTS
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