Our Tech Transfer Advisory service provides expert support for pharmaceutical manufacturing technology transfers. Whether you are transferring from R&D to commercial, between CDMOs, or to a new facility, we ensure smooth, compliant transfers. We develop tech transfer protocols, manage validation activities, and support scale-up from lab to commercial scale.
How our tech transfer advisory service delivers value to your organization.
Comprehensive tech transfer planning including process documentation, timeline, and responsibility matrix.
Process validation strategy and execution support including PPQ protocols and continued process verification.
Scale-up from lab to pilot to commercial scale with process characterization and risk assessment.
Regulatory strategy for manufacturing changes including post-approval change management and comparability protocols.
Comprehensive deliverables that provide actionable intelligence for your team.
A structured methodology that delivers results in four phases.
Develop tech transfer plan including scope, timeline, resources, and risk assessment.
Characterize the process including critical quality attributes and critical process parameters.
Support process validation including PPQ execution and continued process verification.
Support regulatory submissions for manufacturing changes and comparability.
We support R&D to commercial transfers, CDMO to CDMO transfers, CDMO to internal site transfers, and site-to-site transfers for both drug substance and drug product.
Timeline varies by complexity: simple transfers take 6-12 months, complex transfers take 12-24 months. We develop detailed timelines for each engagement.
Yes, we have experience with biologics tech transfer including cell line transfer, upstream/downstream process transfer, and analytical method transfer.
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Learn moreConnect with our team to discuss how our tech transfer advisory service can support your goals.
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