Validation Assistance (Lyophilization, Filling, Isolators, Oral Solid Dosage Equipment, Packaging and Labeling)

Troubleshooting (Equipment and Process)

Scale-up and Process Transfer

Standard Operation Procedures

Batch Production Records

Training

Equipment Validation (Protocol to Final Report)

User Requirement Specification (URS)

Factory Acceptance Testing (FAT)

Site Acceptance Testing (SAT)

Installation Qualification (IQ)

Operation Qualification (OQ)

Process Qualification (PQ)

Troubleshooting

Lyophilization Cycle Optimization

Lyophilizer Problems

Filling Problems

Isolator Problems

Scale-up and Process Transfer

Lab Scale to Manufacturing

Standard Operating Procedures

Flow Diagrams

Technical Documents

Batch Production Records

Flow Diagrams

Validation