Technology Transfer and Documentation

Scale-Up and Registration Batch Manufacturing

We ensure seamless tech transfer through comprehensive documentation:

• Tech Transfer Document Preparation

• Stability Protocol Design (Routine and Special)

• Manufacturing Process Transfer Protocols

• Batch Record Creation (Manufacturing and Packaging)

• Shipping Protocol Development

• Batch Planning and Rationalization Support

• Support in Execution of scale-up and registration batches

• Manufacturing process troubleshooting

• Support in Investigation and resolution of process deviations

• Batch Planning and Rationalization Support