Technology Transfer
We support clients through all stages of Technology Transfer (TT), ensuring both on-time and right-first-time production of comparable product at their receiving sites. Our team has refined and proven our practices over multiple successful tech transfers throughout the different product lifecycle stages (Development to Clinical, Clinical to Commercial, Commercial to Commercial) with involvement as early as receiving site assessment and selection all the way through regulatory filing authorship and site licensure inspection and approval.
Cross-site and cross-functional team facilitation of TT activities including:
Initial risk/feasibility assessment
Facility fit assessment
Conceptual facility design
TT strategy and plan
Integrated control strategy implementation (process, analytical testing, materials, facility)
Risk management
Knowledge management
Operational readiness
Product & process comparability assessments
Approach
Fit-to-purpose application of TT good practices (ISPE Good Practice Guide)
Alignment with industry guidelines (ICH Q8-Q11)
Integrated with process validation stages
Open collaboration and alignment of TT workstreams
Appropriate levels of visibility to key stakeholders
Continuous improvement of practices based on performance and/or success criteria via project review and lessons learned
Trust Forza Pharma Consulting to foster close collaboration between sites and functions to ensure right-first-time receiving site production and successful licensure.
