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

 

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