Tech Transfer Services

The experienced team of project managers support you in the tech transfer process
and have extensive understanding of the commercial manufacturing processes. We
use a risk-based approach and well-established project practices. Transparency
through the project and frequent status reporting will assure you are involved in the
project and decision process.

Tech transfer core activities:

• GAP analysis sending vs receiving unit
• Risk assessment
• Analytical method transfer and verification/validation
• Sourcing and supplier qualification including audit services
• Process optimization including technical batches
• Cleaning validation
• Process validation
• Manufacturing of stability batches
• Stability studies (ICH)
• Regulatory support