Validation Protocol Development and Execution
Process Development and Validation
- Manufacturing Process Development and Validation
- Process Assessment and Optimization (Design of Experiments/SPC)
- Manufacturing Scale-Up
- Technology Transfer
- Technical Report Writing (Validation, etc.)
- Equipment Qualification
- Cleaning Validation
Software/Computer Systems Validation
- Assessment and Remediation of Manufacturing, Laboratory, Medical Device, R&D Facilities and Equipment
- Computer-Controlled – Laboratory Equipment
- Database Management Systems (LIMS, ERP, MRP, MES, EMS, Doc. Management)
- IQ, OQ, PQ Protocols
Laboratory and Analytical Support
- Analytical Method Development and Validation
- Cleaning Validation and Analytical Testing (Verification)
- Equipment Qualification (IQ,OQ,PQ)
- Stability Program Design
- Analytical Testing
Manufacturing and Manufacturing Support
- Cleaning Methods Development (Cleaning Validation)
- Process Cycle Time Reduction
- Water Systems Validation
- Manufacturing Systems Design
- Packaging Process Design and Validation
- Documentation Systems Assessment and Remediation