Technology Transfer Support Services
Our technology transfer framework minimizes risk and preserves product performance when moving processes between sites or partners. We prepare comprehensive transfer master plans, equipment and process specifications, validated analytical method packages, training curricula, and engineering run programs. Transfer activities include comparability studies, process performance qualification (PPQ), cleaning validation, control strategies, and stability study plans to support regulatory filings. We deliver training, SOPs, and hands-on oversight during transfer and provide post-transfer troubleshooting, optimization, and document updates. Clear governance, acceptance criteria, and escalation pathways reduce schedule uncertainty and preserve audit readiness across supply chain transitions and ongoing technical, regulatory, and commercial support.
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What is technology transfer in pharmaceuticals?
Technology transfer is the process of moving a product’s manufacturing process, analytical methods, and related know-how from one site to another while ensuring product quality, regulatory compliance, and commercial readiness.
How do you ensure product quality is maintained during transfer?
We use comparability studies, PPQ batches, and validated analytical methods to confirm that the receiving site produces material equivalent to the original.
Can you support both internal and external transfers?
Yes. We manage technology transfers between internal company sites, as well as to and from external manufacturing partners (CMOs/CDMOs).
What documentation do you provide during transfer?
We supply master plans, process and equipment specifications, analytical method packages, SOPs, training guides, and control strategy documentation.
How do you minimize transfer risks?
Through clear governance, defined acceptance criteria, engineering runs, and proactive troubleshooting, we reduce schedule delays and quality risks.
Do you assist with regulatory submissions related to transfer?
Yes. We prepare stability study plans, comparability data, and validation reports for inclusion in global regulatory filings.
