Technology Transfer
Fully cross-disciplinary, transparent, and collaborative tech transfer to get you into commercial production as quickly and efficiently as possible
Sometimes you need to move your finished product production. Whether your original site can no longer continue or you just need more production volume closer to your market, Technology Transfer is how you make it happen.
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What We Offer
Moving the commercial production of an approved therapeutic is a multidisciplinary activity. There is a long list of important activities that need to be identified, risk assessed, planned, and executed to a detailed timeline. It takes an experienced team working in harmony to make it all happen successfully.
That’s why we offer you a proven comprehensive team approach with cross-functional alignment from day one.
We offer:
- Deep technical manufacturing and analytical expertise
- Transparent, real-time communication
- Culture of collaboration and client partnership
We align experts from all the impacted disciplines to cover key areas for the transfer effort and set us up for successful ongoing commercial supply, such as:
- Project Management
- Quality/Regulatory Strategy (e.g. CBE-30 vs PAS)
- Facility and Equipment
- Raw Materials Supply Chain
- Analytical Methods
- Manufacturing Execution
- Documentation and Filing
- Collaborative Sales and Operations Planning (S&OP)
Our Process
For each area, we take a multistep approach in close collaboration with you to ensure that we successfully:
- Transfer Knowledge
- Analyze Gaps
- Assess Risks
- Identify Solutions for Mitigation
- Plan Execution
- Execute and Document
All under the guidance of an experienced Technical Lead.
This comprehensive team coordinates the activities and documentation for raw materials, analytical methods, production, and packaging, to ensure that we capture, assess and transfer everything necessary for your commercial success.
Design • Develop • Manufacture
Let's build something remarkable