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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